A multicenter randomized controlled clinical study of PPI and H2RA in preventing stress ulcer

Multicenter randomized controlled clinical trial on prevention of stress ulcer in patients with acute myocardial infarction

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045235

Enrollment

Unknown

Registered

2021-04-09

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress ulcer

Interventions

PPI group:Intravenous PPI

H2RAgroup:Intravenous H2RA

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients with acute myocardial infarction undergoing PPCI receive aspirin (75-150 mg/day) and P2Y12 receptor antagonist clopidogrel (75 mg/day) or ticagrelor (120-180 mg/day) (DAPT). 2. Diagnostic criteria for myocardial infarction: (1) The chest pain persists for more than 30 minutes, within 72 hours of onset; (2) After admission, two or more adjacent ST-segment elevations in ECG or a new left bundle branch block, or more than 0.1mv lower than at rest; (3) Myocardial enzymes are significantly increased by more than 3 times the upper limit of normal.

Exclusion criteria

Exclusion criteria: 1. Aspirin or P2Y12 resistance; 2. Those who are allergic to proton pump inhibitors and H2 receptor antagonists; 3. Pregnant or lactating women or women of childbearing age who have not taken effective contraceptive measures; 4. A history of malignant diseases (except those who have recovered for more than 10 years or who have only suffered from skin basal cell carcinoma or skin squamous cell carcinoma), and the life expectancy is less than 3 years; 5. History of peptic ulcer; 6. History of gastrointestinal bleeding.

Design outcomes

Primary

Measure	Time frame
Gastrointestinal bleeding;Fecal occult blood test positive;Hematemesis;Obvious bleeding with hemoglobin drop> 20g/L, or supplementation of red blood cells >=2U;aspirate from the nasogastric tube contains blood or coffee grounds;Black stool or blood in the stool;	—

Secondary

Measure	Time frame
Hospital acquired pneumonia;Clostridium difficile infection;recurrent myocardial infarction;revascularization due to ischemia;myocardial ischemia;liver damage;Acute kidney injury;Central nervous system reaction;death;medical side effects;	—

Countries

China

Contacts

Public ContactLefeng Wang

Beijing Chao-Yang Hospital, Capital Medical University

wlf311@126.com+86 13601255020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026