Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

Comparison of Ulcer Healing in Patients Taking Rabeprazole Plus Aspirin Versus Rabeprazole Plus Clopidogrel for Acute Peptic Ulcer

Clopidogrel causes significantly less peptic ulcer disease (PUD) and ulcer bleeding than low-dose aspirin in general population. However, clopidogrel is not safe enough for gastrointestinal (GI) mucosa in patients who had past history of aspirin-associated ulcer or ulcer bleeding. Aspirin plus proton pump inhibitor (PPI) is superior to clopidogrel alone in preventing recurrent ulcer bleeding in these high risk patients.

This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients with aspirin-associated PUD when they take PPI (rabeprazole 20 mg/day) to treat their PUD and simultaneously take aspirin or clopidogrel for their cardiovascular (CV) prevention. Two hundred patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day) or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks. The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.

If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence of ulcer healing and ulcer bleeding in the healing phase,PPI plus aspirin rather than PPI plus clopidogrel will be recommended during acute ulcer healing in patients who need antiplatelet therapy for their CV prevention.

Study Overview

• Status: Unknown
• Conditions: Gastric Ulcer; Duodenal Ulcer
• Intervention / Treatment: Drug: rabeprazole plus aspirin versus rabeprazole plus clopidogrel

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiing-Chyuan Luo, M.D.; Phone Number: 3346 886-2-28712121; Email: jcluo@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Jiing-Chyuan Luo, M.D.; Phone Number: 3346 886-2-28712121; Email: jcluo@vghtpe.gov.tw
    • Principal Investigator: Jiing-Chyuan Luo, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have taken aspirin for more than 1 month and are found to have PUD by upper endoscopy will receive PPI (rabeprazole 20 mg once daily) to treat their PUD. PUD in the upper gastrointestinal (UGI) tract is defined as

  • [1] mucosal break of stomach or duodenum > 3 mm in diameter; or
  • [2] more than 10 gastric or duodenal erosions, without malignancy proved by histopathological examination.

Exclusion Criteria:

• Patients will be excluded if they have PUD with bleeding (ulcer with adherent blood clot, visible vessel, oozing, or spurting) requiring endoscopic hemostasis,
• if they take other antithrombotic or anticoagulants simultaneously, if they have take NSAIDs, selective COX-2 inhibitors, or steroid,
• if they have take misoprostol or histamine receptor-2 antagonist (H2RA),
• if they have bleeding tendency (thrombocytopenia with platelet count < 80000/mm3 or prolonged pro thrombin time > 5 seconds),
• if they have anemia (hemoglobin < 10 g/dL),
• if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past,
• if their age are > 80 year-old or < 18 year-old,
• if they have severe cardiovascular, pulmonary, hepatic, or renal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aspirin; Patients who have taken aspirin for more than 1 month and are found to have PUD by upper endoscopy will receive PPI (rabeprazole 20 mg once daily) to treat their PUD.patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day) or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks.	Drug: rabeprazole plus aspirin versus rabeprazole plus clopidogrel; The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.
Active Comparator: clopidogrel; Patients who have taken aspirin for more than 1 month and are found to have PUD by upper endoscopy will receive PPI (rabeprazole 20 mg once daily) to treat their PUD.patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day) or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks.	Drug: rabeprazole plus aspirin versus rabeprazole plus clopidogrel; The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary end point is treatment success (ulcer healing rate).	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary end point is incidence of ulcer bleeding within 12 weeks.	3 months

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Luo JC, Huang KW, Leu HB, Chen LC, Hou MC, Li CP, Lu CL, Lin HC, Lee FY, Lee SD. Randomised clinical trial: rabeprazole plus aspirin is not inferior to rabeprazole plus clopidogrel for the healing of aspirin-related peptic ulcer. Aliment Pharmacol Ther. 2011 Sep;34(5):519-25. doi: 10.1111/j.1365-2036.2011.04760.x. Epub 2011 Jul 5.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: December 21, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 8, 2010
• Last Update Submitted That Met QC Criteria: June 6, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: aspirin, clopidogrel, peptic ulcer, proton pump inhibitor, rabeprazole, ulcer bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Stomach Ulcer; Duodenal Ulcer; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Aspirin; Clopidogrel; Rabeprazole
• Other Study ID Numbers: VGH97-10-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No