Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial (POINT)

Study Description

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Brief Summary:

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

Condition or disease	Intervention/treatment	Phase
Ischemic Attack, Transient	Drug: Clopidogrel; Drug: placebo	Phase 3

Detailed Description:

Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, is a prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel (600 mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12 hours of time last known free of new ischemic symptoms.

Its primary objective is to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day (with a dose of 150-200 mg daily for 5 days followed by 75-100 mg daily strongly recommended).

Patients over 18 years of age with high-risk TIA (defined as an ABCD2 score greater than or equal to 4) or minor ischemic stroke (with NIHSS less than or equal to 3) who can be treated within 12 hours of time last known free of new ischemic symptoms will be enrolled.

Subjects will be randomized 1:1 (clopidogrel: placebo), controlling for clinical center. A study participant's eligibility will be determined by site personnel prior to accessing the Randomization Module in the WebDCU™, a web-enabled clinical trials management system that was developed by the NETT Statistics and Data Management Center (SDMC) at Medical University of South Carolina (MUSC).Qualified users will access the Randomization Interface and complete a protocol-specific eligibility checklist. If the Randomization Interface finds the patient to be eligible based on the information provided, a randomization number and a confirmatory e-mail are generated.

Each subject is followed for 90 days from randomization; the trial will be completed in 7 years.

A total of 5,840 patients will be recruited. Recruitment will occur over 90 months, with a goal rate of 0.40 subjects/site/month for US sites, and a goal rate of 0.47 subjects/site/month for OUS sites. Current participating sites can be found at: http://www.pointtrial.org/node/18.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	5840 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Actual Study Start Date :	May 28, 2010
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: clopidogrel; Patients assigned to clopidogrel in addition to aspirin	Drug: Clopidogrel; Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days; Other Name: Plavix
Placebo Comparator: placebo; Patients assigned to placebo in addition to aspirin	Drug: placebo; Loading dose of 8 tablets followed by one tablet daily for 89 days

Outcome Measures

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Primary Outcome Measures :

1. Total number of patients with ischemic stroke within 90 days. [ Time Frame: Up to 90 days ]
2. Total number of patients with myocardial infarction within 90 days. [ Time Frame: Up to 90 days ]
3. Total number of patients with ischemic vascular death within 90 days. [ Time Frame: Up to 90 days ]
4. Total number of patients with major hemorrhage. [ Time Frame: Up to 90 days ]

Secondary Outcome Measures :

1. Intention-to-treat (ITT) analysis of number of patients with major hemorrhage [ Time Frame: Up to 90 days ]
2. As-treated analysis of number of patients with major hemorrhage [ Time Frame: Up to 90 days ]
3. ITT analysis of number of patients with ischemic stroke [ Time Frame: Up to 90 days ]
4. As-treated analysis of number of patients with ischemic stroke [ Time Frame: Up to 90 days ]
5. ITT analysis of number of patients with myocardial infarction [ Time Frame: Up to 90 days ]
6. As-treated analysis of number of patients with myocardial infarction [ Time Frame: Up to 90 days ]
7. ITT analysis of number of patients with ischemic vascular death [ Time Frame: Up to 90 days ]
8. As-treated analysis of number of patients with ischemic vascular death [ Time Frame: Up to 90 days ]
9. ITT analysis of number of patients with hemorrhagic stroke [ Time Frame: Up to 90 days ]
10. As-treated analysis of number of patients with hemorrhagic stroke [ Time Frame: Up to 90 days ]
11. ITT analysis of number of patients with ischemic stroke from day 0 to 7 [ Time Frame: Day 0-7 ]
12. As-treated analysis of number of patients with ischemic stroke from day 0 to 7 [ Time Frame: Day 0-7 ]
13. ITT analysis of number of patients with ischemic stroke from day 8 to 90 [ Time Frame: Day 8-90 ]
14. As-treated analysis of number of patients with ischemic stroke from day 8 to 90 [ Time Frame: Day 8-90 ]
15. ITT analysis of number of patients with ischemic stroke from day 0 to 30 [ Time Frame: Day 0-30 ]
16. As-treated analysis of number of patients with ischemic stroke from day 0 to 30 [ Time Frame: Day 0-30 ]
17. ITT analysis of number of patients with ischemic stroke from day 31 to 90 [ Time Frame: Day 31-90 ]
18. As-treated analysis of number of patients with ischemic stroke from day 31 to 90 [ Time Frame: Day 31-90 ]
19. ITT analysis of number of patients with myocardial infarction from day 0 to 7 [ Time Frame: Day 0-7 ]
20. As-treated analysis of number of patients with myocardial infarction from day 0 to 7 [ Time Frame: Day 0-7 ]
21. ITT analysis of number of patients with myocardial infarction from day 8 to 90 [ Time Frame: Day 8-90 ]
22. As-treated analysis of number of patients with myocardial infarction from day 8 to 90 [ Time Frame: Day 8-90 ]
23. ITT analysis of number of patients with myocardial infarction from day 0 to 30 [ Time Frame: Day 0-30 ]
24. As-treated analysis of number of patients with myocardial infarction from day 0 to 30 [ Time Frame: Day 0-30 ]
25. ITT analysis of number of patients with myocardial infarction from day 31 to 90 [ Time Frame: Day 31-90 ]
26. As-treated analysis of number of patients with myocardial infarction from day 31 to 90 [ Time Frame: Day 31-90 ]
27. ITT analysis of number of patients with ischemic vascular death from day 0 to 7 [ Time Frame: Day 0-7 ]
28. As-treated analysis of number of patients with ischemic vascular death from day 0 to 7 [ Time Frame: Day 0-7 ]
29. ITT analysis of number of patients with ischemic vascular death from day 8 to 90 [ Time Frame: Day 8-90 ]
30. As-treated analysis of number of patients with ischemic vascular death from day 8 to 90 [ Time Frame: Day 8-90 ]
31. ITT analysis of number of patients with ischemic vascular death from day 0 to 30 [ Time Frame: Day 0-30 ]
32. As-treated analysis of number of patients with ischemic vascular death from day 0 to 30 [ Time Frame: Day 0-30 ]
33. ITT analysis of number of patients with ischemic vascular death from day 31 to 90 [ Time Frame: Day 31-90 ]
34. As-treated analysis of number of patients with ischemic vascular death from day 31 to 90 [ Time Frame: Day 31-90 ]
35. ITT analysis of number of patients with all‐cause death [ Time Frame: Up to 90 days ]
36. As-treated analysis of number of patients with all‐cause death [ Time Frame: Up to 90 days ]
37. ITT analysis of number of patients with symptomatic intracerebral hemorrhage [ Time Frame: Up to 90 days ]
38. As-treated analysis of number of patients with symptomatic intracerebral hemorrhage [ Time Frame: Up to 90 days ]
39. ITT analysis of number of patients with other symptomatic intracranial hemorrhage, including SAH, SDH or IVH [ Time Frame: Up to 90 days ]
40. As-treated analysis of number of patients with other symptomatic intracranial hemorrhage, including SAH, SDH or IVH [ Time Frame: Up to 90 days ]
41. ITT analysis of number of patients with major hemorrhage other than intracranial hemorrhage [ Time Frame: Up to 90 days ]
42. As-treated analysis of number of patients with major hemorrhage other than intracranial hemorrhage [ Time Frame: Up to 90 days ]
43. ITT analysis of number of patients with all minor hemorrhage [ Time Frame: Up to 90 days ]
44. As-treated analysis of number of patients with all minor hemorrhage [ Time Frame: Up to 90 days ]

Other Outcome Measures:

1. Number of patients with TIA as outcome [ Time Frame: Up to 90 days ]
2. Number of patients with coronary revascularization [ Time Frame: Up to 90 days ]
3. Number of patients with vascular death [ Time Frame: Up to 90 days ]
4. Number of patients with SAEs together using MedDRA Body System [ Time Frame: Up to 90 days ]
5. Number of patients with SAEs by major class using MedDRA Body System [ Time Frame: Up to 90 days ]
6. Number of patients with new handicap or disability defined as 90 day mRS >=2 [ Time Frame: Up to 90 days ]
7. Number of patients with 90 day mRS score ordinal [ Time Frame: Up to 90 days ]
8. Number of patients with asymptomatic intracranial hemorrhage, including ICH, SAH, SDH or IVH [ Time Frame: Up to 90 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Neurological deficit (based on history or exam) attributed to focal brain ischemia and EITHER:

  • High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score of (greater than or equal to) 4 OR
  • Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3 at the time of randomization
• Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
• Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
• Ability to tolerate aspirin at a does of 50-325 mg/day.

Exclusion Criteria

• Age <18 years
• TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
• In the judgment of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.
• Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
• Gastrointestinal bleed or major surgery within 3 months prior to index event.
• History of nontraumatic intracranial hemorrhage.
• Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
• Qualifying ischemic event induced by angiography or surgery.
• Severe non-cardiovascular comorbidity with life expectancy <3 months.

• Contraindication to clopidogrel or aspirin.

  • Known allergy
  • Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency (prior or concurrent diagnosis, with International Normalized Ratio (INR)>1.5 or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
  • Hemostatic disorder or systemic bleeding in the past 3 months
  • Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia (<1 x10^9/l)
  • History of drug-induced hematologic or hepatic abnormalities
• Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).
• Inability to swallow medications.
• At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
• Unavailability for follow-up.
• Signed and dated informed consent not obtained from patient.
• Other neurological conditions that would complicate assessment of outcomes during follow-up.
• Ongoing treatment in another study of an investigational therapy that may potentially interact with study drug, or treatment in such a study within the last 7 days.
• Previously enrolled in the POINT study.

Contacts and Locations

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Locations

United States, Arizona
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States, 85724
United States, California
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
UCSD Health La Jolla
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Desert Regional Medical Center
Palm Springs, California, United States, 92262
Huntington Memorial Hospital
Pasadena, California, United States, 91105
UC Davis Medical Center
Sacramento, California, United States, 95817
Mercy General Hospital
Sacramento, California, United States, 95819
Scripps Mercy Hospital San Diego
San Diego, California, United States, 92103
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States, 92103
San Francisco General Hospital
San Francisco, California, United States, 94110
UCSF Medical Center
San Francisco, California, United States, 94143
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Stanford, California, United States, 94305
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States, 91360
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University of Colorado Hospital
Aurora, Colorado, United States, 80045
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Englewood, Colorado, United States, 80113
St. Anthony Hospital
Lakewood, Colorado, United States, 80228
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Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
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Christiana Hospital
Newark, Delaware, United States, 19713
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Washington, District of Columbia, United States, 20037
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UF Health Shands Hospital
Gainesville, Florida, United States, 32608
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Jacksonville, Florida, United States, 32209
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Sarasota, Florida, United States, 34239
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Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
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Atlanta, Georgia, United States, 30308
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Augusta, Georgia, United States, 30912
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the Queen's Medical Center
Honolulu, Hawaii, United States, 96813
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Chicago, Illinois, United States, 60611
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Guilford Neurologic Associates
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Summa Akron City Hospital
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Providence, Rhode Island, United States, 02903
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Medical University of South Carolina University Hospital
Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29203
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Vanderbilt University Hospital
Nashville, Tennessee, United States, 37323
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University Medical Center Brackenridge
Austin, Texas, United States, 78701
Seton Medical Center
Austin, Texas, United States, 78705
Texas Health Presbyterian Hospital - Dallas
Dallas, Texas, United States, 75231
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, United States, 78550
Ben Taub General Hospital
Houston, Texas, United States, 77030
Houston Methodist Hospital
Houston, Texas, United States, 77030
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
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UVA Medical Center
Charlottesville, Virginia, United States, 22908
Bon Secours St. Francis Medical Center
Richmond, Virginia, United States, 23114
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States, 23226
Henrico Doctors' Hospital - Forest Campus
Richmond, Virginia, United States, 23229
Henrico Doctors' Hospital - Parham Campus
Richmond, Virginia, United States, 23294
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, West Virginia
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, United States, 26505
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Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States, 53211
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
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Gosford Hospital
Gosford, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Northern Hospital
Epping, Victoria, Australia
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Footscray, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
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University of Calgary - Foothills Campus
Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada
Canada, Quebec
Charles LeMoyne Hospital
Greenfield Park, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Notre-Dame Hospital
Montreal, Quebec, Canada
Canada
Enfant-Jesus Hospital
Quebec, Canada
Finland
Helsinki University Central Hospital
Helsinki, Finland
Turku University Hospital
Turku, Finland
France
Fleyriat Hospital
Bourg-en-Bresse, France
Pierre Wetheimer Hospital
Bron, France
Adolphe de Rothschild Ophthalmologic Foundation
Paris, France
Bichat-Claude Bernard Hospital
Paris, France
Pitie-Salpetriere Hospital
Paris, France
Foch Hospital
Suresnes, France
Germany
University Hospital of Ulm
Ulm, Baden-Württemberg, Germany, 89081
Neurological Clinic Bad Neustadt
Bad Neustadt an der Saale, Germany
Vivantes Hospital Neukolln
Berlin, Germany
Central Bremen Hospital
Bremen, Germany
University Hospital Essen
Essen, Germany
University Hospital Frankfurt
Frankfurt, Germany
University Medical Center Hamburg
Hamburg, Germany
Hannover Medical School
Hannover, Germany
University Hospital Heidelberg
Heidelberg, Germany
University Hospital Schleswig-Holstein Kiel Campus
Kiel, Germany
University Medical Center Leipzig
Leipzig, Germany
University Hospital Munster
Munster, Germany
Mexico
Mexican Association for Clinical Research
Pachuca, Hidalgo, Mexico
Central Hospital Dr. Ignacio Morones Prieto
San Luis Potosí, San Luis Potosi, Mexico, 78240
Culiacan General Hospital
Culiacan, Sinaloa, Mexico
Neurosciences Clinical Trials
Culiacan, Sinaloa, Mexico
ABC Medical Center Santa Fe
Mexico City, Mexico
New Zealand
Auckland City Hospital
Auckland, New Zealand
Spain
Hospital del Mar
Barcelona, Spain
Santa Creu and Sant Pau Hospital
Barcelona, Spain
Vall d'Hebron Hospital
Barcelona, Spain
Basurto Hospital
Bilbao, Spain
Burgos University Hospital
Burgos, Spain
Hospital Donostia
Donostia, Spain
Girona University HOspital
Girona, Spain
La Fe University Hospital
Valencia, Spain
Miguel Servet Hospital
Zaragoza, Spain
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
The Royal London Hospital
London, United Kingdom
University College Hospital
London, United Kingdom
Luton and Dunstable University Hospital
Luton, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Royal United Hospital - Bath
Somerset, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom

Sponsors and Collaborators

University of California, San Francisco

Neurological Emergencies Treatment Trials Network (NETT)

Medical University of South Carolina

The EMMES Corporation

Investigators

Principal Investigator:	S. Claiborne Johnston, MD, PhD	University of Texas, Austin
Principal Investigator:	J. Donald Easton, MD	University of California, San Francisco
Principal Investigator:	Anthony S. Kim, MD, MAS	University of California, San Francisco

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Publications:

Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18. Review.

Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. Epub 2007 Nov 13. Review.

Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1.

Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4.

Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27.

Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400.

Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. Epub 2007 Oct 10.

Geisler T, Zürn C, Paterok M, Göhring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.

Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.

Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. Epub 2004 Mar 15.

Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barillà F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.

Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. Epub 2007 Jul 10.

Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. Epub 2003 Aug 18.

Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Büttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.

Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6.

Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.

Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54.

Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9.

Lavallée PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Lesèche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60.

Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.

Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.

Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

Brown RD Jr, Petty GW, O'Fallon WM, Wiebers DO, Whisnant JP. Incidence of transient ischemic attack in Rochester, Minnesota, 1985-1989. Stroke. 1998 Oct;29(10):2109-13.

Kissela B, Broderick J, Woo D, Kothari R, Miller R, Khoury J, Brott T, Pancioli A, Jauch E, Gebel J, Shukla R, Alwell K, Tomsick T. Greater Cincinnati/Northern Kentucky Stroke Study: volume of first-ever ischemic stroke among blacks in a population-based study. Stroke. 2001 Jun;32(6):1285-90.

Williams GR, Jiang JG, Matchar DB, Samsa GP. Incidence and occurrence of total (first-ever and recurrent) stroke. Stroke. 1999 Dec;30(12):2523-8.

Kleindorfer D, Panagos P, Pancioli A, Khoury J, Kissela B, Woo D, Schneider A, Alwell K, Jauch E, Miller R, Moomaw C, Shukla R, Broderick JP. Incidence and short-term prognosis of transient ischemic attack in a population-based study. Stroke. 2005 Apr;36(4):720-3. Epub 2005 Feb 24.

Edlow JA, Kim S, Pelletier AJ, Camargo CA Jr. National study on emergency department visits for transient ischemic attack, 1992-2001. Acad Emerg Med. 2006 Jun;13(6):666-72. Epub 2006 Apr 11.

Howard G, Toole JF, Frye-Pierson J, Hinshelwood LC. Factors influencing the survival of 451 transient ischemic attack patients. Stroke. 1987 May-Jun;18(3):552-7.

Shah KH, Kleckner K, Edlow JA. Short-term prognosis of stroke among patients diagnosed in the emergency department with a transient ischemic attack. Ann Emerg Med. 2008 Mar;51(3):316-23. doi: 10.1016/j.annemergmed.2007.08.016. Epub 2007 Oct 25. Review. Erratum in: Ann Emerg Med. 2008 Jun;51(6):774.

Wu CM, McLaughlin K, Lorenzetti DL, Hill MD, Manns BJ, Ghali WA. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med. 2007 Dec 10;167(22):2417-22. Review.

Gladstone DJ, Kapral MK, Fang J, Laupacis A, Tu JV. Management and outcomes of transient ischemic attacks in Ontario. CMAJ. 2004 Mar 30;170(7):1099-104.

Lisabeth LD, Ireland JK, Risser JM, Brown DL, Smith MA, Garcia NM, Morgenstern LB. Stroke risk after transient ischemic attack in a population-based setting. Stroke. 2004 Aug;35(8):1842-6. Epub 2004 Jun 10.

Eliasziw M, Kennedy J, Hill MD, Buchan AM, Barnett HJ; North American Symptomatic Carotid Endarterectomy Trial Group. Early risk of stroke after a transient ischemic attack in patients with internal carotid artery disease. CMAJ. 2004 Mar 30;170(7):1105-9.

Hill MD, Yiannakoulias N, Jeerakathil T, Tu JV, Svenson LW, Schopflocher DP. The high risk of stroke immediately after transient ischemic attack: a population-based study. Neurology. 2004 Jun 8;62(11):2015-20.

Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36.

Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. Epub 2003 Jul 10.

Rao SV, Ohman EM, Granger CB, Armstrong PW, Gibler WB, Christenson RH, Hasselblad V, Stebbins A, McNulty S, Newby LK. Prognostic value of isolated troponin elevation across the spectrum of chest pain syndromes. Am J Cardiol. 2003 Apr 15;91(8):936-40.

Whisnant JP, Matsumoto N, Elveback LR. Transient cerebral ischemic attacks in a community. Rochester, Minnesota, 1955 through 1969. Mayo Clin Proc. 1973 Mar;48(3):194-8.

Humphrey PR, Marshall J. Transient ischemic attacks and strokes with recovery prognosis and investigation. Stroke. 1981 Nov-Dec;12(6):765-9.

Putman SF, Adams HP Jr. Usefulness of heparin in initial management of patients with recent transient ischemic attacks. Arch Neurol. 1985 Oct;42(10):960-2.

Biller J, Bruno A, Adams HP Jr, Godersky JC, Loftus CM, Mitchell VL, Banwart KJ, Jones MP. A randomized trial of aspirin or heparin in hospitalized patients with recent transient ischemic attacks. A pilot study. Stroke. 1989 Apr;20(4):441-7.

Dennis M, Bamford J, Sandercock P, Warlow C. Prognosis of transient ischemic attacks in the Oxfordshire Community Stroke Project. Stroke. 1990 Jun;21(6):848-53.

Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. Epub 2004 Jan 26.

Daffertshofer M, Mielke O, Pullwitt A, Felsenstein M, Hennerici M. Transient ischemic attacks are more than "ministrokes". Stroke. 2004 Nov;35(11):2453-8. Epub 2004 Oct 14.

Whitehead MA, McManus J, McAlpine C, Langhorne P. Early recurrence of cerebrovascular events after transient ischaemic attack. Stroke. 2005 Jan;36(1):1; author reply 1.

Correia M, Silva MR, Magalhães R, Guimarães L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. Epub 2005 Dec 1.

Purroy F, Molina CA, Montaner J, Alvarez-Sabín J. Absence of usefulness of ABCD score in the early risk of stroke of transient ischemic attack patients. Stroke. 2007 Mar;38(3):855-6; author reply 857. Epub 2007 Jan 18.

Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.

Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.

Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.

Johnston SC, Easton JD, Farrant M, Barsan W, Battenhouse H, Conwit R, Dillon C, Elm J, Lindblad A, Morgenstern L, Poisson SN, Palesch Y. Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke. 2013 Aug;8(6):479-83. doi: 10.1111/ijs.12129.

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00991029 History of Changes
Other Study ID Numbers:	1U01S062835-01A1
First Posted:	October 7, 2009
Last Update Posted:	May 7, 2018
Last Verified:	May 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by University of California, San Francisco:

Transient Ischemic Attack; TIA; minor stroke

Additional relevant MeSH terms:

Ischemia; Ischemic Attack, Transient; Pathologic Processes; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases	Clopidogrel; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs