Status:
COMPLETED
Gastrointestinal Ulceration in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine the rate of symptomatic and asymptomatic gastrointestinal erosions and ulcerations in patients on dual antiplatelet (aspirin and clopidogrel) therapy after percutaneous coronary intervent...
Detailed Description
Background and Significance: Percutaneous coronary intervention (PCI) is the standard of care for patients with acute coronary syndrome (ACS). Approximately 1,200,000 PCIs were performed in 2002 in t...
Eligibility Criteria
Inclusion
- Patients who have undergone PCI within the preceding 72 hrs
- Patients on aspirin and clopidogrel
- Age greater than 18 years and less than 80 years
- Written informed consent
Exclusion
- Active bleeding
- Pregnancy
- Patients already on H2 antagonists
- Patients already on PPI
- Patients with implanted cardiac defibrillator (ICD)
- Patients with GI strictures, swallowing disorders, or bowel obstruction and fistulas.
- Patients with significant gastrointestinal diverticular disease
- Patients likely to require MRI imaging during the time the PillCam is still in the digestive tract (8 to 72 hours after the PillCam procedure)
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00413309
Start Date
April 1 2006
End Date
December 1 2008
Last Update
February 4 2009
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115