acute myocardial infarction with ST segment elevation MedDRA version: 8.1 Level: LLT Classification code 10064345
Conditions
Interventions
Trade Name: AGGRASTAT 250 microgram/ml
Product Name: Tirofiban
Product Code: MK-383
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tirofiban
CAS Number: NA
Current Spo
Sponsors
ISALA KLINIEKEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females >= 21 years of age 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigatre the effect of pre-hospital treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 600 mg Clopidogrel) on the extent of residual ST segment deviation 1 hour after Primary Coronary Angioplasty for acute myocardial infarction, compared to no pre-treatment (besides Aspirin, Heparin and 600 mg Clopidogrel).;Secondary Objective: 1. To investigate the effect of pre-hospital treatment with a high bolus dosage of Tirofiban on the incidence of the combined occurrence of death, recurrent MI, urgent TVR or thrombotic bailout at 30 days follow-up, compared to no pre-treatment. 2. To investigate the effect of pre-hospital treatment with a high bolus dosage of Tirofiban on the incidence of major bleeding compared to no pre-treatment. 3. To investigate the effect of pre-hospital treatment with a high bolus dosage of Tirofiban on the incidence of TIMI 3 flow of the infarct related vessel (IRV) at initial angiography, compared to no pre-treatment.;Primary end point(s): To investigate the effect of pre-treatment with 25 microgram/kg bolus and maintenance infusion Tirofiban on the amount of residual cumulative ST deviation 1 hour after Primary Coronary Angioplasty for acute mypcardial infarction, compared to no pre-treatment. The absolute level of the ST segment deviation will be measured by digital caliper to the nearest 0.01 mv 20ms after the end of the QRS interval using the TP segment as isoclectic baseline. | — |
Countries
Germany
Outcome results
None listed