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Clinical Trials/EUCTR2009-014343-36-DE
EUCTR2009-014343-36-DEActive, not recruitingNot Applicable

RANDOMIZED TRIAL OF PRASUGREL PLUS BIVALIRUDIN VERSUS CLOPIDOGREL PLUS HEPARIN IN PATIENTS WITH ACUTE STEMI BAVARIAN REPERFUSION ALTERNATIVES EVALUATION [BRAVE-4] TRIAL - BRAVE-4

Deutsches Herzzentrum0 sites1,240 target enrollmentStarted: August 20, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
1,240
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1.Patients presenting within 24 hours from the onset of symptoms, with chest pain lasting = 20 minutes and with = 0.1 mV of ST-segment elevation in = 2 adjacent limb leads or = 0.2 mV in = 2 contiguous precordial leads or new left bundle branch block on surface ECG
  • •2.Informed, written consent
  • •3.In women with childbearing potential a pregnancy test is obligatory.
  • •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
  • •1.Patients presenting within 24 hours from the onset of symptoms, with chest pain lasting = 20 minutes and with = 0.1 mV of ST-segment elevation in = 2 adjacent limb leads or = 0.2 mV in = 2 contiguous precordial leads or new left bundle branch block on surface ECG
  • •2.Informed, written consent
  • •3.In women with childbearing potential a pregnancy test is obligatory.
  • •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
  • •2. Cardiogenic shock or prolonged cardio-pulmonary resuscitation
  • •3.Active bleeding; bleeding diathesis; coagulopathy
  • •4.History of gastrointestinal or genitourinary bleeding within the previous 2 months
  • •5.Refusal to receive blood transfusion
  • •6.Major surgery in the last 6 weeks
  • •7.History of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation)
  • •8.Suspected aortic dissection;
  • •9. TIA within the last two weeks
  • •10.Heparin-induced thrombocytopenia
  • •11.Any previous stroke
  • •12.Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
  • •13.Known relevant hematological deviations:
  • •hemoglobin < 100 g/l
  • •platelet count < 100 x 109 cells/l
  • •14.Use of coumadin derivatives within the last 7 days
  • •15.Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cyclooxygenase-2 inhibitors, prasugrel.
  • •16.Known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
  • •17.Known severe liver disease
  • •18.Known severe renal failure with GFR <30 ml/min and/or dialysis
  • •19.Known allergy to the study medications
  • •20.Previous enrollment in this trial
  • •21.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.
  • •22.Patient’s inability to fully cooperate with the study protocol
  • •1.Age < 18 years
  • •2. Cardiogenic shock or prolonged cardio-pulmonary resuscitation
  • •3.Active bleeding; bleeding diathesis; coagulopathy
  • •4.History of gastrointestinal or genitourinary bleeding within the previous 2 months
  • •5.Refusal to receive blood transfusion
  • •6.Major surgery in the last 6 weeks
  • •7.History of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation)
  • •8.Suspected aortic dissection;
  • •9. TIA within the last two weeks
  • •10.Heparin-induced thrombocytopenia
  • •11.Any previous stroke
  • •12.Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
  • •13.Known relevant hematological deviations:
  • •hemoglobin < 100 g/l
  • •platelet count < 100 x 109 cells/l
  • •14.Use of coumadin derivatives within the last 7 days
  • •15.Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cyclooxygenase-2 inhibitors, prasugrel.
  • •16.Known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
  • •17.Known severe liver disease
  • •18.Known severe renal failure with GFR <30 ml/min and/or dialysis
  • •19.Known allergy to the study medications
  • •20.Previous enrollment in this trial
  • •21.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.
  • •22.Patient’s inability to fully cooperate with the study protocol

Investigators

Sponsor
Deutsches Herzzentrum

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