Primary percutaneous coronary intervention (PCI) for ST-elevation Myocardial Infarction (STEMI) MedDRA version: 8.1 Level: LLT Classification code 10028596 Term: Myocardial infarction
Conditions
Interventions
Trade Name: Integrilin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: eptifibatide
CAS Number: 188627-80-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
GlaxoSmithKline Research, European Medical Governance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject = 18 years of age. Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible) 2. Acute myocardial infarction 20 min and b. ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I. 3. planned primary percutaneous coronary intervention 4. The subject has given written informed, dated consent to participate in the study 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
Exclusion criteria: 1. Subjects not able to give informed consnet 2. Left Bundle Branch Block 3. Thrombolytic therapy within 24 hours before randomization 4. Oral anticoagulation with INR > 2 5. Known platelets < 100.000/µl or known hemorrhagic diathesis 6. Stroke or TIA within the past 6 months or any permanent residual neurological defect 7. Evidence of an active gastrointestinal or urogenital bleeding 8. Major surgery within 6 weeks 9. History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media) 10. Known severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as ALT/AST elevations = 3xULN; isolated AST-elevation is not considered an exclusion criteria from study participitation. 11. Severe concomitant disease with life expectation < 1 year 12. Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study. 13. Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up 14. In France, a subject is neither affiliated with nor a beneficiary of a social security category.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Incidence of complete sum-ST resolution (= 70%) 60 (range 45-75) minutes after procedure (ECG III), as compared to the baseline (pre-randomization) ECG (ECG I), assessed by a core ECG laboratory.;Main Objective: To demonstrate non-inferiority of eptifibatide compared with abciximab as adjunct in patients undergoing primary PCI for STEMI.;Secondary Objective: To assess measures of reperfusion success (CK-MB/Troponin release; TIMI-flow pre- and post-procedure; TIMI Myocardial Perfusion Grade (TMPG)) as well as effect on death, re-MI, UTVR, stroke, bleeding complications and medical resource utilization in patients undergoing primary PCI for STEMI. | — |
Countries
Germany
Outcome results
None listed