A study to compare two treatments to patients with STEMI or NSTEMI. The study will evaluate all cause death, myocardial infarction, stroke, stent trombosis and bleeding after treated with PCI - Percutaneous coronary interventio

Phase 1

Conditions: Patients with STEMI and NSTEMI treated with PCI and either Bivalirudin (optional to add up to 3000U heparin in lab or up to 5000U given prehospital ) compared to Heparin 70 - 100U/kg alone
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
MedDRA version: 17.1Level: LLTClassification code 10064347Term: Non ST segment elevation myocardial infarctionSystem Organ Class: 100000004849
MedDRA version: 17.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849

Registration Number: EUCTR2012-005260-10-SE

Lead Sponsor: ppsala Clinical Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6000

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).
- Ability to provide informed consent
- Age 18 years or older
- Treated with bolus dose of ticagrelor or prasugrel before start of PCI

Age 18 years or older

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3000

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 dysfunctions
- Patients with known thrombocytopenia or thrombocyte function defects
- Any other contraindication for the study medications
- Heparin >5000U before arriving to PCI lab or >3000U given during angiography before randomization
- GpIIb/IIIa-inhibitors have been given or are pre-planned to be given during the procedure.