Abciximab versus Eptifibatide versus Bivalirudin during PCI in patients with acute coronary syndromes

• Conditions: ST elevation myocardial infarction and non ST elevation myocardial infarction/unstable angina; MedDRA version: 9.1Level: LLTClassification code 10000920Term: Acute myocardial infarction, subendocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10002385Term: Angina pectoris unstable

• Registration Number: EUCTR2009-009039-32-SE
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age over 18 years.
2.Patients with STEMI, treated with primary PCI or patients with NSTEMI treated with PCI.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Intolerance to abciximab, eptifibatide, tirofiban, ASA eller clopidogrel.
Increased risk for bleedings
Patients with prior hemmoragic stroke
Patients with ischemic stroke the last 6 months
Patients with gastrointestinal or genitourinary bleeding the last two months
Patients with ongoing warfarin or oral thrombin inhibitor treatment
Patients treated recently with thrombolysis (rescue PCI)
History of Heparin induced trombocytopenia (HIT)
Known platelet count =100.000 per deciliter
Known hemoglobin level = 10mg per deciliter
Known renal failure with serum creatinine levels over 200 µmol/L
History of prior myocardial infarction
History of medically treated angina pectoris
History of prior PCI or CABG
Patients presenting with cardiogenic shock
Presence of systemic disease with a less than a year expected life duration
Patient`s unweeling in participating in the study
Difficulties in communication between the medical stuff and the patient, even due to language problems or due to the patients` disease status

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare three different anticoagulation strategies during PCI in terms of platelet aggregation and neutrofiles activation;Secondary Objective: To compare three different anticoagulation strategies during PCI in terms of clinical efficacy and safety;Primary end point(s): Platelet activation measured with multiple electrode aggregometry immediately after PCI with TRAP as agonist.<br> <br>