Status:
COMPLETED
Patterns of Non-Adherence to Dual Anti-Platelet Regimen In Stented Patients
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Bristol-Myers Squibb
Sanofi
Conditions:
Medication Non-adherence
Stent Thrombosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantati...
Detailed Description
Anti-platelet medicines are the cornerstone of therapy in patients who present with acute coronary syndromes, including unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevati...
Eligibility Criteria
Inclusion
- The subject has been informed of the nature of the study, agrees to its provisions, and has signed and been provided an "Informed Consent Form" approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
- The subject must be ≥18 of age (or minimum age as required by local regulations) at the time of enrollment with successful stent placement in one or more lesions in native coronary arteries using an approved coronary stent.
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV), OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III), OR subjects with documented silent ischemia, OR acute myocardial infarction.
- The subject is willing and able to cooperate with the study procedures and required follow-ups.
Exclusion
- Subjects with hypersensitivity or allergies to anti-platelet therapy.
- Subjects in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following the index procedure.
- The subject is participating in an investigational device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study.
- Subject has a history of bleeding diathesis or coagulopathy.
- Subject has other medical illness (e.g., cancer, known malignancy or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the followups as defined by the protocol or confound the data interpretation.
- Evidence of stent thrombosis by visual angiographic assessment during the index procedure.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
5031 Patients enrolled
Trial Details
Trial ID
NCT00998127
Start Date
June 1 2009
End Date
March 1 2013
Last Update
February 11 2016
Active Locations (15)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
3
University of Kentucky
Lexington, Kentucky, United States, 40536
4
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912