Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01037491
First received: December 21, 2009
Last updated: June 6, 2010
Last verified: June 2010

December 21, 2009
June 6, 2010
October 2009
December 2010   (final data collection date for primary outcome measure)
The primary end point is treatment success (ulcer healing rate). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01037491 on ClinicalTrials.gov Archive Site
The secondary end point is incidence of ulcer bleeding within 12 weeks. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Ulcer
  • Duodenal Ulcer
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: 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.
    Intervention: Drug: rabeprazole plus aspirin versus rabeprazole plus clopidogrel
  • 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.
    Intervention: Drug: rabeprazole plus aspirin versus rabeprazole plus clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Jiing-Chyuan Luo, M.D. 886-2-28712121 ext 3346 jcluo@vghtpe.gov.tw
Taiwan
 
NCT01037491
VGH97-10-04
Not Provided
Fang-Yue Lin, Superintendent, Taipei Veterans General Hospital
Taipei Veterans General Hospital, Taiwan
Not Provided
Not Provided
Taipei Veterans General Hospital, Taiwan
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP