Current partner codePEPTIDESDE
NCT03882775·Phase 4·INTERVENTIONAL

Bivalirudin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction

Status

Unknown

Phase

Phase 4

Enrollment

240

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.

Interventions

Treatment arms and agents.

DRUG

Bivalirudin

Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.

DRUG

Heparin

heparin with or without gpi during emergency PCI.

Timeline

From registration to results.

  1. First posted

    Mar 20, 2019

  2. Study start

    Jan 16, 2019

  3. Primary completion

    Jul 14, 2020

  4. Study completion

    Dec 31, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Mar 20, 2019

Outcomes

What the study measures.

Primary outcomes

Major adverse cardiac events

Time frame · 7 days

a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina,Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

Major bleeding

Time frame · 7 days

BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Secondary outcomes

Major adverse cardiac events

Time frame · 30 days

a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina,Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

Stent thrombosis ,TVR ,TLR

Time frame · 30 days

rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

Major adverse cardiac events

Time frame · 180 days

a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina,Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

Stent thrombosis ,TVR ,TLR

Time frame · 180 days

rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

Eligibility

Who can take part.

Minimum age
75 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Age ≥75 years old; * Planned emergency (Symptom onset within 24h) PCI for acute STEMI patients; * Life expectancy ≥ 1 year; * Provide written informed consent. Exclusion Criteria: * Contraindications to angiography or PCI; * Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc; * Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.); * Severe renal insufficiency (eGFR \< 30 mL/min/ 1.73 m2); * Elevated AST, ALT level higher than three times of the normal upper limit; * Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ) * Complicated with immune system diseases; * Abnormal hematopoietic system:platelet count \< 100 \* 109 / L or \> 700 \* 109 / L,white blood cell count \< 3 \* 109/L etc; * Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors; * Known intolerance, or contraindication to any antithrombotic medication * Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. * Non-cardiac co-morbid conditions are present that may result in protocol non-compliance; * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; * Patient's inability to fully cooperate with the study protocol

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.