Ongoing 2b/3a inhibition In Myocardial infarction EvaluationA 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

Phase 1

Active, not recruiting

• Conditions: Acute Myocardial infarctio

• Registration Number: EUCTR2006-000303-42-BE
• Lead Sponsor: Diagram B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-09
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 985

Inclusion Criteria

1. Males or females > 21 years of age and < 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 expectancy of < 1year
2) Patient is pregnant or breastfeeding
3) Patients with left bundle branch block
4) Subject who have received thrombolytic therapy within 24 hours or warfarin in last 7 days or another GpIIb/IIIa within last 30 days
5) Subject who have known severe renal dysfunction (GFR<30ml/min or serum creatinine >2.5 mg/dl or 200mmmol/l) or receiving dialysis or previously undertaken renal transplantation
6) Confirmed or persistent severe hypertension (Systolic b.p. > 180 mmHg and/or diastolic b.p. >110 mmHg) at randomization
7) Subjects with a contraindication to anticoagulation or at increased bleeding risk
a. Past or present history (<1 year) of bleeding from gastrointestinal (haematemesis) malena, frank bleed in stool or visible haematuria
b. Known thrombocytopenia, platelet count (<100,00/mm3 ) or coagulopathy or platelet disorder
c. History of hemorrhagic TIA, CVA (last 6 months), intracranial pathology (neoplasm, aneurysm, AV malformation)
d. History of major recent (<30 day) surgery or trauma
e. Known presence of retinopathy or pericarditis or recent epidural procedure
8) Patients who have received another investigational drug or device or participated in any clinical trial within 4 weeks prior to randomization
9) Patients in cardiogenic shock (SBP ,80mmHg for >30 mins) or needing IABP
10) Known Hb <11gm/dl or HCT <33%
11) Hypersensitivity to any component of Tirofiban or ASA or Heparin or clopidogrel

Study & Design

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