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

NCT00413309 | Completed DMC

• 1 other identifier: 2006-P-000376
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 intervention (PCI).

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Percutaneous Coronary Intervention; Antiplatelet Therapy; PillCam; Endoscopy

Outcome Measures

Primary Outcomes (3)

• A composite of overt and occult GI bleeding, gastritis, and esophageal, gastric, or duodenal ulcerations.

  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.

  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.

  90 Days

Interventions

Video Capsule Endoscopy PROCEDURE

Noninvasive pill endoscopy is undertaken after 90 days of Aspirin/Clopidogrel in patients who have had percutaneous coronary intervention with drug-eluting stents.

Also known as: PillCam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (21)

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Related Links

• North American Thrombosis Forum

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Videotape Recording; Endoscopy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Samuel Z. Goldhaber, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

US (1)