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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00413309
First received: December 15, 2006
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00413309

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

Additional Information:
Publications:
Smith SC Jr, Dove JT, Jacobs AK, Kennedy JW, Kereiakes D, Kern MJ, Kuntz RE, Popma JJ, Schaff HV, Williams DO, Gibbons RJ, Alpert JP, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty); Society for Cardiac Angiography and Interventions. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)-executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation. 2001 Jun 19;103(24):3019-41. No abstract available.
Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; Canadian Cardiovascular Society. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). Circulation. 2004 Aug 31;110(9):e82-292. No abstract available. Erratum in: Circulation. 2005 Apr 19;111(15):2013-4.

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
Study First Received: December 15, 2006
Last Updated: February 2, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014