PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER TRIAL OF ABCIXIMAB AND BIVALIRUDIN IN PATIENTS WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS - ISAR-REACT-4

• Conditions: Acute Coronary Syndrome; MedDRA version: 8.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2006-002085-19-DE
• Lead Sponsor: Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-15
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

1.Patients with an episode of angina (with an accelerating pattern or prolonged [>20minutes] or recurrent episodes at rest or with minimal effort) within the preceding 48 hours.
2.Elevated cardiac markers above the upper normal limit (Troponin or CK-MB)
3.Angiographic lesions requiring PCI.
4.Informed, written consent by the patient or her/his legally-authorized representative for participation 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

1.Age =18 years and >80 years.
2.ST-segment elevation acute myocardial infarction (ST-segment =0.1 mV elevation in =2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
3.Cardiogenic shock.
4.Pericarditis
5.Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance.
6.Active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; pericarditis; and patient’s refusal to blood transfusion.
7.Oral anticoagulation therapy with coumarin derivative within the last 7 days.
8.Recent use of GPIIb/IIIa inhibitors within 14 days.
9.Treatment with unfractionated heparin within 4 hours unless an ACT is less than 150 or low-molecular weight heparin within 8 hours before randomization.
10.Treatment with bivalirudin within 24 hours before randomization.
11.Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy
12.Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
13.Relevant hematologic deviations:
hemoglobin < 100 g/L
platelet count < 100 x 109 cells/L or platelet count > 600 x 109 cells/L.
14.Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine >30 mg/L or dependence on renal dialysis.
15.Known allergy or intolerance to the study medications: aspirin, abciximab, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
16.Previous enrollment in this trial.
17.Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding.
18.Patient’s inability to fully cooperate with the study protocol.
19.Other contraindication according to the summary of product characteristics of ReoPro®, Angiox® or Heparin-Natrium®.

Study & Design

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