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Gastrointestinal Ulceration in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 19, 2006
Last Update Posted: February 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
To determine the rate of symptomatic and asymptomatic gastrointestinal erosions and ulcerations in patients on dual antiplatelet (aspirin and clopidogrel) therapy after percutaneous coronary intervention (PCI).

Condition Intervention
Acute Coronary Syndrome Procedure: Video Capsule Endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastrointestinal Ulceration in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • A composite of overt and occult GI bleeding, gastritis, and esophageal, gastric, or duodenal ulcerations. [ Time Frame: 90 Days ]
  • Overt GI symptoms include GI bleeding requiring hospitalization, blood transfusion, and/or interventions like endoscopy or surgery or gastroesophageal acid reflux (GERD) requiring acid-suppressive therapy. [ Time Frame: 90 Days ]
  • Occult GI ulcerations and erosions include those detected by capsule endoscopy (PillCamÒ ESO) within 80 to 90 days after initiation of dual antiplatelet therapy. [ Time Frame: 90 Days ]

Estimated Enrollment: 30
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Video Capsule Endoscopy
    Noninvasive pill endoscopy is undertaken after 90 days of Aspirin/Clopidogrel in patients who have had percutaneous coronary intervention with drug-eluting stents.
    Other Name: PillCam
  Show Detailed Description


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

Inclusion Criteria:

  1. Patients who have undergone PCI within the preceding 72 hrs
  2. Patients on aspirin and clopidogrel
  3. Age greater than 18 years and less than 80 years
  4. Written informed consent

Exclusion Criteria:

  1. Active bleeding
  2. Pregnancy
  3. Patients already on H2 antagonists
  4. Patients already on PPI
  5. Patients with implanted cardiac defibrillator (ICD)
  6. Patients with GI strictures, swallowing disorders, or bowel obstruction and fistulas.
  7. Patients with significant gastrointestinal diverticular disease
  8. 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)
  Contacts and Locations
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): NCT00413309

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital
  More Information

Additional Information:
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Responsible Party: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00413309     History of Changes
Other Study ID Numbers: 2006-P-000376
First Submitted: December 15, 2006
First Posted: December 19, 2006
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Brigham and Women's Hospital:
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Antiplatelet Therapy

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

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