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

May 18, 2017 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6012

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bivalirudin
bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour
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.
Other Names:
  • Angiox
Active Comparator: heparin
unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice
Drug: 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
Other Names:
  • Heparin 5000 IU/ml i.v. ,Leo Pharma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death, Myocardial infarction and major bleeding event
Time Frame: 180 days
180 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Lund University

Investigators

  • Principal Investigator: David Erlinge, Lund University, Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT nr: 2012-005260-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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