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Short-term effects of proton-pump inhibitors on gastric and small intestinal mucosa in patients with acute coronary syndromes at low risk for gastrointestinal bleeding: a randomized controlled clinical trial

Short-term effects of proton-pump inhibitors on gastric and small intestinal mucosa in patients with acute coronary syndromes at low risk for gastrointestinal bleeding: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068551
Enrollment
Unknown
Registered
2023-02-23
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

acute coronary syndromes

Interventions

Test group:Aspirin (100mg, qd, orally) and ticagrelor (90mg, bid, orally) combined with rabeprazole (20mg/ day, qd, orally)
Control group:Aspirin (100mg, qd, orally) and ticagrelor (90mg, bid, orally)

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-80 years, male or female; 2. Patients diagnosed as unstable angina or non-ST-segment elevation myocardial infarction for the first time, low and moderate risk ischemia with GRACE score < 140; 3. Dual antibody therapy with aspirin (100mg/day) and ticagrelor (180mg/day); 4. Agree to comply with all study procedures and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Active gastrointestinal bleeding or ulceration, or a history of gastrointestinal bleeding or ulceration within 24 months; 2.Long term oral anticoagulant; 3.Received related drugs that have influence on the experiment, including antibiotics, probiotics, drugs that inhibit gastric acid secretion and affect gastrointestinal flora in the past one month; 4.There are contraindications of magnetic controlled capsule endoscopy, such as intestinal obstruction, stenosis, diverticulum, fistula, etc., and a history of abdominal surgery to change the anatomical structure of the stomach and intestine, and refuse to undergo any abdominal surgery (once the capsule is incarcerated, surgical removal is required); 5. Combined with active cancer; 6. Severe renal insufficiency, eGFR 3 times upper limit; 10. Severe hypertension (> 180/100 mmHg) that has not been controlled; 11.Severe hemorrhoids (stage 3-4, according to American Society for Colorectal Surgery guidelines); 12.Planning pregnancy or surgery; 13.Conditions that affect the research process, such as dementia and mobility problems; 14.There are other ongoing clinical studies.

Design outcomes

Primary

MeasureTime frame
the damage of stomach ;the damage of small intestine;gut microbiota;Clinical bleeding;

Countries

China

Contacts

Public ContactJie Zhang

Beijing Anzhen Hospital, Capital Medical University

zhangjie4155@sina.com+86 18911662871

Outcome results

None listed

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