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

Uppsala University

Status and phase

Completed

Phase 4

Conditions

ST-segment Elevation Myocardial Infarction

Non ST-segment Elevation Myocardial Infarction

Treatments

Drug: Heparin

Drug: bivalirudin

Study type

Interventional

Funder types

Other

Identifiers

NCT02311231

EudraCT nr: 2012-005260-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,012 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.