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Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

Primary Purpose

Gastric Ulcer, Duodenal Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

rabeprazole plus aspirin versus rabeprazole plus clopidogrel

About this trial

This is an interventional treatment trial for Gastric Ulcer focused on measuring aspirin, clopidogrel, peptic ulcer, proton pump inhibitor, rabeprazole, ulcer bleeding

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

aspirin

clopidogrel

Arm Description

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.

Outcomes

Primary Outcome Measures

The primary end point is treatment success (ulcer healing rate).

Secondary Outcome Measures

The secondary end point is incidence of ulcer bleeding within 12 weeks.

Full Information

NCT ID

NCT01037491

First Posted

December 21, 2009

Last Updated

June 6, 2010

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01037491

Brief Title

Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Ulcer, Duodenal Ulcer

Keywords

aspirin, clopidogrel, peptic ulcer, proton pump inhibitor, rabeprazole, ulcer bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aspirin

Arm Type

Active Comparator

Arm Description

Arm Title

clopidogrel

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

rabeprazole plus aspirin versus rabeprazole plus clopidogrel

Intervention Description

The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.

Primary Outcome Measure Information:

Title

The primary end point is treatment success (ulcer healing rate).

Time Frame

3 months

Secondary Outcome Measure Information:

Title

The secondary end point is incidence of ulcer bleeding within 12 weeks.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiing-Chyuan Luo, M.D.

Phone

886-2-28712121

Ext

3346

jcluo@vghtpe.gov.tw

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiing-Chyuan Luo, M.D.

Phone

886-2-28712121

Ext

3346

jcluo@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

Jiing-Chyuan Luo, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

21726257

Citation

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.

Results Reference

derived

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Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

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