This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT02270242
Previous Study | Return to List | Next Study

Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Roxana Mehran, Icahn School of Medicine at Mount Sinai
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Roxana Mehran, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02270242
First received: October 15, 2014
Last updated: January 27, 2017
Last verified: January 2017
  Purpose

The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot that could block blood flow to the heart. This study will look to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among high-risk patients who have had a percutaneous intervention with at least one drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria.

Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting randomization eligibility criteria at 3 months post enrollment will be randomized to either ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.


Condition Intervention Phase
Cardiovascular Disease Interventional Cardiology Drug: Aspirin Drug: Placebo Drug: ticagrelor Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
Official Title: Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Roxana Mehran, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Bleeding episode [ Time Frame: 12 months ]
    the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding.


Secondary Outcome Measures:
  • Ischemic episode [ Time Frame: 12 months ]
    the time to first occurrence of confirmed cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization


Estimated Enrollment: 9000
Study Start Date: July 2015
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin + Ticagrelor
enteric coated aspirin 81mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 15 months
Drug: Aspirin
Other Name: Ecotrin
Drug: ticagrelor
Other Names:
  • Brilinta
  • Brilique
Placebo Comparator: Placebo + Ticagrelor
placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg and ticagrelor 90mg tablet bid for 15 months
Drug: Placebo Drug: ticagrelor
Other Names:
  • Brilinta
  • Brilique

Detailed Description:

This is a multicenter, prospective, blinded dual-arm study. Up to 9000 high-risk patients who have undergone successful elective or urgent PCI with at least one locally approved drug eluting stent discharged on DAPT with aspirin and ticagrelor of at least 3 months intended duration from centers still to be determined in the U.S., Canada, Europe and Asia. The primary objective of this study is to determine the impact of antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months in reducing clinically relevant bleeding (efficacy) among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.

The secondary objective of this study is to determine the impact of antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months in reducing major ischemic adverse events (safety) among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.

Exploratory objectives include assessing the comparative safety and efficacy of the different DAPT regimens for individual components of the primary efficacy and secondary safety objectives.

  Eligibility

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

Inclusion Criteria:

  • High-risk patients who have undergone successful elective or urgent PCI with at least one locally approved drug eluting stent discharged on DAPT with aspirin and ticagrelor of at least 3 months intended duration will be eligible for the TWILIGHT study.
  • Enrollment into the study will require meeting at least one clinical inclusion, one angiographic inclusion and none of the exclusion criteria.

Clinical Inclusion Criteria:

  • Adult patients ≥ 65 years of age
  • Female gender
  • Troponin Positive acute coronary syndrome
  • Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
  • Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
  • Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 or creatinine clearance (CrCl) < 60 ml/min

Angiographic Inclusion Criteria:

  • Multivessel coronary artery disease
  • Target lesion requiring total stent length >30 mm
  • Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
  • Left main (≥50%) or proximal LAD (≥70%) lesion
  • Calcified target lesion requiring atherectomy

Exclusion Criteria:

  • Under 18 years of age
  • Contraindication to aspirin
  • Contraindication to ticagrelor
  • Planned surgery within 90 days
  • Planned coronary revascularization (surgical or percutaneous) within 90 days
  • Need for chronic oral anticoagulation
  • Prior stroke
  • Dialysis-dependent renal failure
  • Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
  • Emergent or salvage PCI or STEMI presentation.
  • Liver cirrhosis
  • Life expectancy < 1 year
  • Unable or unwilling to provide informed consent
  • Women of child bearing potential. Defined: a woman is considered potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • Fibrinolytic therapy within 24 hours of index PCI
  • Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
  • Platelet count < 100,000 mm3
  • Requiring ongoing treatment with aspirin > 325 mg daily
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02270242

Contacts
Contact: Pamela Kivitz 212-659-8372 Pamela.Kivitz@mountsinai.org
Contact: Theresa Franklin-Bond, PA-C 212-659-9647 theresa.franklin-bond@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Roxana Mehran, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
AstraZeneca
Investigators
Study Director: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Study Chair: Usman Baber, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. Erratum in: Circulation. 2008 Mar 4;117(9):e180.
Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation. 2004 Aug 3;110(5):588-636. Erratum in: Circulation. 2005 Apr 19;111(15):2013.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24.

Responsible Party: Roxana Mehran, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02270242     History of Changes
Other Study ID Numbers: GCO 14-1383
Study First Received: October 15, 2014
Last Updated: January 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Roxana Mehran, Icahn School of Medicine at Mount Sinai:
PCI
DAPT
ticagrelor
aspirin

Additional relevant MeSH terms:
Cardiovascular Diseases
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 21, 2017