Trial Outcomes & Findings for Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer (NCT NCT01138969)

NCT ID: NCT01138969

Last Updated: 2015-09-09

Results Overview

Number of participants with recurrent peptic ulcer within 6 months

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 165 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-09-09

Participant Flow

1. Dates of the recruitment period: From August 2008 to August 2012 2. Type of location: Kaohsiung Veterans General Hospital

None were excluded following participant enrollment.

Participant milestones

Measure	Esomeprazole Plus Clopidogrel Group esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months	Clopidogrel Group clopidogrel 75 mg qd for 6 months
Overall Study STARTED	83	82
Overall Study COMPLETED	83	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Baseline characteristics by cohort

Measure	Esomeprazole Plus Clopidogrel Group n=83 Participants esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months	Clopidogrel Group n=82 Participants clopidogrel 75 mg qd for 6 months	Total n=165 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Age, Continuous	70.6 years STANDARD_DEVIATION 11.5 • n=5 Participants	73.3 years STANDARD_DEVIATION 10.7 • n=7 Participants	72.0 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	59 Participants n=7 Participants	124 Participants n=5 Participants
Region of Enrollment Taiwan	83 participants n=5 Participants	82 participants n=7 Participants	165 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat

Number of participants with recurrent peptic ulcer within 6 months

Outcome measures

Measure	Esomeprazole Plus Clopidogrel Group n=83 Participants esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months	Clopidogrel Group n=82 Participants clopidogrel 75 mg qd for 6 months
Recurrent Peptic Ulcer	1 participants	9 participants

SECONDARY outcome

Timeframe: 6 months

Population: Intention to treat

participants with peptic ulcer bleeding within 6 months

Outcome measures

Measure	Esomeprazole Plus Clopidogrel Group n=83 Participants esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months	Clopidogrel Group n=82 Participants clopidogrel 75 mg qd for 6 months
Peptic Ulcer Bleeding	0 participants	1 participants

Adverse Events

Esomeprazole Plus Clopidogrel Group

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Clopidogrel Group

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Esomeprazole Plus Clopidogrel Group n=83 participants at risk esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months	Clopidogrel Group n=82 participants at risk clopidogrel 75 mg qd for 6 months
Cardiac disorders acute myocardial infarct	2.4% 2/83 • Number of events 2 • 6 months	2.4% 2/82 • Number of events 2 • 6 months

Other adverse events

Measure	Esomeprazole Plus Clopidogrel Group n=83 participants at risk esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months	Clopidogrel Group n=82 participants at risk clopidogrel 75 mg qd for 6 months
Cardiac disorders unstable angina	1.2% 1/83 • Number of events 1 • 6 months	1.2% 1/82 • Number of events 1 • 6 months

Additional Information

Dr. Ping-I Hsu

KaohsiungVGH

Phone: 886-7-3462121

Email: pihsu@isca.vghks.gov.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place