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Randomized controlled clinical study on the effect of early oral rivaroxaban on the prognosis of patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI

Randomized controlled clinical study on the effect of early oral rivaroxaban on the prognosis of patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070526
Enrollment
Unknown
Registered
2023-04-14
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Acute

Interventions

Rivaroxaban group:Rivaroxaban (5 mg St / 10 mg st) + aspirin 300 mg + clopidogrel bisulfate 300 mg or ticagrelor 180 mg
placebo group:Placebo + aspirin 300mg + clopidogrel bisulfate 300mg or ticagrelor 180mg

Sponsors

Yueyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 (2) For the first STEMI, the diagnostic criteria are in accordance with the Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction, and the following points must be met: ? Ischemic post-sternal pain attack lasts for more than 20-30 minutes; ? ECG has two or more adjacent leads with ST segment elevation (limb lead>0.1mv, precordial lead>0.2mv) or new left bundle branch block; ? With or without serum markers, at least 99% of the reference value; ? See a doctor within 12 hours after the onset of STEMI.

Exclusion criteria

Exclusion criteria: ? Patients who are unable to perform PCI directly and have not opened blood vessels after PCI due to various reasons; ? Patients who cannot be followed up for prognosis due to various reasons; ? The relevant important time node data is inaccurate or incomplete; ? Patients who have undergone thrombolytic therapy; ? Poor basic condition, serious impairment of liver and kidney function, known clinical history of human immunodeficiency virus infection, drug abuse (drug or alcohol), problems in the past 6 months or any serious disease, such as cancer that limits life expectancy to less than 12 months; ? High blood pressure (systolic blood pressure>200mmHg or diastolic blood pressure>120mmHg); ? There are contraindications to anticoagulation (major surgery, biopsy of parenchymal organs or severe trauma, severe anemia, active bleeding, history of stroke in the past three months and other situations that aggravate the risk of bleeding); ? Platelet count is lower than 50 * 109/ul during screening; ? The international standardization ratio higher than 1.5 is known at the time of screening; ? Other anticoagulant drugs, including heparin, low molecular weight heparin, warfarin, have been used before operation.

Design outcomes

Primary

MeasureTime frame
major adverse cardiac events;

Secondary

MeasureTime frame
Cardiac related rehospitalization and all-cause death;

Countries

China

Contacts

Public ContactGang Pan

Yueyang Central Hospital

stent1974@126.com+86 13975084961

Outcome results

None listed

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