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Efficacy and safety of Bivarudine in post-thrombolytic PCI in patients with ST-segment elevation myocardial infarction: a multicentre, prospective, randomized controlled trial

Efficacy and safety of Bivarudine in post-thrombolytic PCI in patients with ST-segment elevation myocardial infarction: a multicentre, prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035602
Enrollment
Unknown
Registered
2020-08-14
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

ST-segment elevation myocardial infarction

Interventions

Bivalirudin group:Bivalirudin
Heparin group:Heparin

Sponsors

Tangdu Hospital of Air Force Millitary Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. STEMI patients with onset time = 1 mm, or new left bundle branch block); 3. Patients who have received pre hospital / in-hospital thrombolytic therapy; 4. Patients who plan to undergo routine PCI / rescue PCI within 24 hours after thrombolysis; 5. Thrombolytic drugs used in thrombolytic therapy were patients with specific plasminogen activator (alteplase, prourokinase, reteplase, teneplase); 6. Patients who had been treated with intravenous heparin anticoagulant therapy in the early stage of thrombolysis; 7. The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, can guarantee compliance, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial hemorrhage or stroke of unknown cause at any time in the past; 2. Patients with ischemic stroke or transient cerebral ischemia in recent 6 months; 3. Patients with central nervous system injury, tumor or arteriovenous malformation; 4. Patients with severe trauma / operation / head injury and gastrointestinal bleeding in recent 1 month; 5. Patients with bleeding diseases of known causes (excluding menstruation); 6. Patients with clear, highly suspected or unable to exclude aortic dissection; 7. Patients who received non compression puncture within 24 hours (such as liver biopsy and lumbar puncture); 8. After active antihypertensive treatment, the blood pressure of patients with hypertension was still >= 180 / 110 mmHg; 9. Pregnant or lactating women; 10. Patients with advanced liver disease; 11. Patients with severe or end-stage CKD (EGFR < 30ml / min); 12. Patients with mechanical complications (such as ventricular septal rupture, papillary muscle rupture, acute mitral regurgitation, etc.); 13. Patients treated with oral anticoagulants (warfarin, etc.); 14. Patients who used anticoagulants other than heparin and bivalirudin 48 hours before operation, such as enoxaparin and fondaparinux sodium; The Patient is allergic to clopidogrel, clopidogrel or clopidogrel; 16. Patients who have participated in the study of other drugs / devices or during the follow-up period of another drug / device study; 17. Patients may not comply with the study protocol (including the follow-up period), such as mental disorders, alcohol or drug use.

Design outcomes

Primary

MeasureTime frame
30 days all due to death or BARC 3-5 bleeding;

Secondary

MeasureTime frame
NACE;MACCE;Intrastent thrombosis;BARC 2-5 hemorrhage;BARC 3-5 hemorrhage;Acquired thrombocytopenia;

Countries

China

Contacts

Public ContactLi Yan

Tangdu Hospital of Air Force Millitary Medical University

307712565@qq.com+86 13892890227

Outcome results

None listed

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