Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART

Phase 4

Completed

• Conditions: ST-segment Elevation Myocardial Infarction; Non ST-segment Elevation Myocardial Infarction
• Interventions: Drug: Heparin; Drug: bivalirudin

• Registration Number: NCT02311231
• Lead Sponsor: Uppsala University

Brief Summary

In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.

Detailed Description

The follow up of endpoints will be performed using SWEDEHEART and national registries. Follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The nurses will also accumulate hospital record information on these endpoints.

A central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. Every site will prepare source documents for the event and send it to UCR for central adjudication by an independent committee.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6012

Inclusion Criteria

• Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
• PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
• Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
• Ability to provide informed consent
• Age 18 years or older

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Exclusion Criteria

• Previous randomization in the VALIDATE-SWEDEHEART trial.
• Known terminal disease with life expectancy less than one year.
• Patients with known ongoing bleeding
• Patients with uncontrolled hypertension in the opinion of the investigator
• Patients with known subacute bacterial endocarditis
• Patients with known severe renal (GFR < 30 ml/min) and/or liver dysfunction
• Patients with known thrombocytopenia or thrombocyte function defects
• Any other contraindication for the study medications.
• Heparin > 5000U Before arriving to PCI lab or > 3000 U given during angiography before randomization.
• GpIIb/IIIa inhibitors have been given or are pre-planned to be given during the procedure.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
heparin	Heparin	unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice
bivalirudin	bivalirudin	bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour

Primary Outcome Measures

Name	Time	Method
Death, Myocardial infarction and major bleeding event	180 days

Secondary Outcome Measures

Name	Time	Method
TIMI flow grade after PCI	180 days
Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI	180 days
Time to primary endpoints (death, myocardial infarction and major bleeding event)	180 days	Time to individual components of the primary end point (death, myocardial infarction and major bleeding).
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered	180 days	The primary end point combined with stroke as reported in the Swedish national patient registry.
Minor bleeding during index hospitalization	180 days	Minor bleeding during index hospitalization as reported in SWEDEHEART
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) have been registered in heparin subgroups (U/kg, groups with certain max ACT values etc)	180 days
Time to all-cause death or re-hospitalization with myocardial infarction	180 days
Time to stent thrombosis	180 days	Time to stent thrombosis as reported in SWEDEHEART.
Time to re-hospitalization with reinfarction	180 days	Time to re-hospitalization with reinfarction as reported in Swedeheart
Time to target lesion revascularization	180 days	Time to target lesion revascularization as reported in SWEDEHEART
Time to re-hospitalization with heart failure	180 days	Time to re-hospitalization with heart failure as reported in SWEDEHEART.
Heart failure and complications of PCI during index hospitalization	180 days	Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART
Time to target vessel revascularization	180 days	Time to target vessel revascularization as reported in SWEDEHEART.
Time to restenosis	180 days	Time to restenosis as reported in SWEDEHEART.
Length of index hospital stay	180 days	Length of index hospital stay as reported in SWEDEHEART
Bail-out use of GpIIb/IIIa	180 days	Bail-out use of GpIIb/IIIa inhibitors during PCI

Trial Locations

Locations (1)

Lund University; 🇸🇪 Lund, Sweden