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

ST-segment Elevation Myocardial Infarction Clinical Trial

— VALIDATE  

Official title:

Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311231
• Other study ID #: EudraCT nr: 2012-005260-10
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2014
• Last updated: May 18, 2017
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6012
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non ST-segment Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

Drug:
• bivalirudin
Will be administered as an intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour). Bivalirudin will be administered alone or with a low dose of heparin up to 3000U heparin in lab or up to 5000 U given pre-hospital according to local practice.
• Heparin
Treatment with unfractionated Heparin 5000 IU/ml i.v. ,Leo Pharma, Sweden, (the control group). Heparin in the control group is administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100 U/kg is recommended

Locations

Country	Name	City	State
Sweden	Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

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