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Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I (PRACTICE I)

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ClinicalTrials.gov Identifier: NCT00684359
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 31, 2010
Sponsor:
Information provided by:
Medstar Health Research Institute

Brief Summary:

Single center randomized parallel group study to determine if:

  1. there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
  2. the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. And the association with MACE up to 12 months post coronary angioplasty.

Condition or disease
Coronary Disease

Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Retrospective
Official Title: Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
Study Start Date : June 2007
Study Completion Date : February 2010



Primary Outcome Measures :
  1. To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. To determine what the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. [ Time Frame: up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, male or female, > 18 years of age; who are scheduled for an elective PCI with a drug eluting stent; willing to return for all required follow up visit and live/work within a 60 mile radius of the Washington Hospital Center.
Criteria

Inclusion Criteria:

  • Patients, male or female, > 18 years of age,
  • Patients who are scheduled for an elective PCI with a drug eluting stent
  • Patients willing to return for all required follow up visits.
  • Patients live/work within a 60 mile radius of the Washington Hospital Center.

Exclusion Criteria:

  • Patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
  • Unprotected left main coronary disease with >50% stenosis;
  • Patients with renal failure requiring dialysis;
  • Patients with a documented ejection fraction < 30 percent at the time of subsequent PCI;
  • Patient with a life expectancy less than 12 months or malignancy.
  • Known allergies to aspirin or clopidogrel bisulfate (PlavixR) and that cannot be medically managed;
  • Planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of PCI;
  • Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
  • Patients with known history of bleeding diathesis;
  • Prothrombin time >1.5 times control; coumadin therapy
  • Platelet count <100 000/mm3;
  • Hematocrit <25%;
  • Creatinine >4.0 mg/dL;
  • Thienopyridine use within 5 days of enrollment
  • Glycoprotein (GP) IIb/IIIa use within 8 hours of enrollment or any indication were the operator will require GP IIb/IIIa inhibitor use during the hospitalization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684359


Locations
United States, District of Columbia
Ron Waksman, MD, Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute

Responsible Party: Ron Waksman, MD, MedStar Research Institute/Cardiovascular Research Institute
ClinicalTrials.gov Identifier: NCT00684359     History of Changes
Other Study ID Numbers: PRACTICE I
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2010

Keywords provided by Medstar Health Research Institute:
Patients having PCI with a drug eluting stent

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases