Gastrointestinal Ulceration in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - Full Text View

Sponsors and Collaborators:	Brigham and Women's Hospital AstraZeneca
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00413309

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

MedlinePlus related topics: Endoscopy

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Gastrointestinal Ulceration in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

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Eligibility

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

Criteria

Inclusion Criteria:

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 Criteria:

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)

Contacts and Locations

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

North American Thrombosis Forum This link exits the ClinicalTrials.gov site

Publications:

Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30.

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.

Patti G, Colonna G, Pasceri V, Pepe LL, Montinaro A, Di Sciascio G. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2005 Apr 26;111(16):2099-106. Epub 2005 Mar 6.

Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. Epub 2004 Jul 19.

Muller I, Seyfarth M, Rudiger S, Wolf B, Pogatsa-Murray G, Schomig A, Gawaz M. Effect of a high loading dose of clopidogrel on platelet function in patients undergoing coronary stent placement. Heart. 2001 Jan;85(1):92-3. 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.

Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. Erratum in: N Engl J Med 2001 Dec 6;345(23):1716. N Engl J Med 2001 Nov 15;345(20):1506.

Weil J, Colin-Jones D, Langman M, Lawson D, Logan R, Murphy M, Rawlins M, Vessey M, Wainwright P. Prophylactic aspirin and risk of peptic ulcer bleeding. BMJ. 1995 Apr 1;310(6983):827-30.

Peters RJ, Mehta SR, Fox KA, Zhao F, Lewis BS, Kopecky SL, Diaz R, Commerford PJ, Valentin V, Yusuf S; Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) Trial Investigators. Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes: observations from the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) study. Circulation. 2003 Oct 7;108(14):1682-7. Epub 2003 Sep 22.

Kelly JP, Kaufman DW, Jurgelon JM, Sheehan J, Koff RS, Shapiro S. Risk of aspirin-associated major upper-gastrointestinal bleeding with enteric-coated or buffered product. Lancet. 1996 Nov 23;348(9039):1413-6.

Ma L, Elliott SN, Cirino G, Buret A, Ignarro LJ, Wallace JL. Platelets modulate gastric ulcer healing: role of endostatin and vascular endothelial growth factor release. Proc Natl Acad Sci U S A. 2001 May 22;98(11):6470-5. Epub 2001 May 15.

Lau WC, Gurbel PA, Watkins PB, Neer CJ, Hopp AS, Carville DG, Guyer KE, Tait AR, Bates ER. Contribution of hepatic cytochrome P450 3A4 metabolic activity to the phenomenon of clopidogrel resistance. Circulation. 2004 Jan 20;109(2):166-71. Epub 2004 Jan 5.

Rivkin K, Lyakhovetskiy A. Treatment of nonvariceal upper gastrointestinal bleeding. Am J Health Syst Pharm. 2005 Jun 1;62(11):1159-70. Review.

Levine JE, Leontiadis GI, Sharma VK, Howden CW. Meta-analysis: the efficacy of intravenous H2-receptor antagonists in bleeding peptic ulcer. Aliment Pharmacol Ther. 2002 Jun;16(6):1137-42.

Koch M, Dezi A, Ferrario F, Capurso I. Prevention of nonsteroidal anti-inflammatory drug-induced gastrointestinal mucosal injury. A meta-analysis of randomized controlled clinical trials. Arch Intern Med. 1996 Nov 11;156(20):2321-32.

Yeomans ND, Tulassay Z, Juhasz L, Racz I, Howard JM, van Rensburg CJ, Swannell AJ, Hawkey CJ. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med. 1998 Mar 12;338(11):719-26.

Miner P Jr, Katz PO, Chen Y, Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol. 2003 Dec;98(12):2616-20.

Chan FK, Ching JY, Hung LC, Wong VW, Leung VK, Kung NN, Hui AJ, Wu JC, Leung WK, Lee VW, Lee KK, Lee YT, Lau JY, To KF, Chan HL, Chung SC, Sung JJ. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005 Jan 20;352(3):238-44.

Johnson DA, Benjamin SB, Vakil NB, Goldstein JL, Lamet M, Whipple J, Damico D, Hamelin B. Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety. Am J Gastroenterol. 2001 Jan;96(1):27-34. Erratum in: Am J Gastroenterol 2001 Mar;96(3):942.

Maton PN, Vakil NB, Levine JG, Hwang C, Skammer W, Lundborg P; Esomeprazole Study Investigators. Safety and efficacy of long term esomeprazole therapy in patients with healed erosive oesophagitis. Drug Saf. 2001;24(8):625-35.

Eliakim R, Sharma VK, Yassin K, Adler SN, Jacob H, Cave DR, Sachdev R, Mitty RD, Hartmann D, Schilling D, Riemann JF, Bar-Meir S, Bardan E, Fennerty B, Eisen G, Faigel D, Lewis BS, Fleischer DE. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005 Aug;39(7):572-8.

Responsible Party:	Brigham and Women's Hospital ( Samuel Z. Goldhaber, MD )
Study ID Numbers:	2006-P-000376
Study First Received:	December 15, 2006
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00413309
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

Study placed in the following topic categories:

Heart Diseases
Aspirin
Clopidogrel
Myocardial Ischemia

Ulcer
Acute Coronary Syndrome
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009