A randomized, double blind controlled trial evaluating the benefits of early up-front-loaded high dose Tirofiban in the treatment of patients with ST-segment elevation myocardial infarction, who are candidates for primary angioplasty - On-Time-2

• Conditions: acute myocardial infarction with ST segment elevation; MedDRA version: 8.1Level: LLTClassification code 10064345

• Registration Number: EUCTR2006-000303-42-DE
• Lead Sponsor: ISALA KLINIEKE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 958

Inclusion Criteria

1. Males or females >= 21 years of age <= 85 years with symptoms of acute myocardial infarction of more than 30 minutes but less than 24 hours.
2. ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more.
3. Patients should only be included if there is a reasonable expectation that PCI will be conducted within 2 hours.
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. Patients who are unable to give informed consent or have life expectanc of < 1 year.
2. Patient with left bundle branch block.
3. Patients who have received thrombolytic therapy within 24 hours or warfarin in last 7 days or another GpIIb/IIIa within last 30 days.
4. Patients who have known severe renal dysfunction or receiving dialysis or previously undertaken renal transplantation.
5. Patients with confirmed or persistent severe hypertension at randomization.
6. Patients with a contraindication to anticoagulation ar at increased bleeding risk.
7.Patients who have received another investigational drug or device or participated in any clinical trial within 4 weeks prior to randomization
8. Patients in cardiogenic shock or needing IABP.
9. Patients with known Hb < 11 gm/gl or HCT < 33%.
10. Hypersensitivity to any component of Tirofiban or Aspirin or Heparin or Clopidogrel.

Study & Design

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