Patterns of Non-Adherence to Dual Anti-Platelet Regimen In Stented Patients

Completed

Conditions studied: Medication Non-adherence, Stent Thrombosis

In brief

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 implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.

Key facts

Study ID

NCT00998127

Run by

Icahn School of Medicine at Mount Sinai

People needed

5031

Starts

2009-06-01

Expected to finish

2013-03-01

Last updated by the study team

2016-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Heart Center of Indiana — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Saint Luke's/ Mid-America Heart Institute — Kansas City, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States
• Geisinger Medical Center Clinic — Danville, Pennsylvania, United States
• Hopital Bichat — Paris, France
• Charite - Campus Benjamin Franklin — Berlin, Germany
• Onassis Cardiac Surgery Center — Athens, Greece
• Careggi Hospital — Florence, Italy
• San Raffaele Hospital — Milan, Italy

Full record on ClinicalTrials.gov

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