Current partner codePEPTIDESDE
NCT04046029·Phase 4·INTERVENTIONAL

Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

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 coronary syndrome undergoing elective percutaneous coronary intervention.

Interventions

Treatment arms and agents.

DRUG

Bivalirudin

Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.

DRUG

Heparin

Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.

Timeline

From registration to results.

  1. First posted

    Aug 6, 2019

  2. Study start

    Jul 8, 2019

  3. Primary completion

    Jul 30, 2020

  4. Study completion

    Jun 30, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Aug 6, 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

Major bleeding

Time frame · 30 days

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

Major bleeding

Time frame · 180days

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

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 elective PCI for patients with acute coronary syndrome; * 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, 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.