Ongoing 2b/3a inhibition In Myocardial infarction Evaluation.

A Randomized, 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20108

Enrollment

950

Registered

2005-08-03

Start date

2004-04-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Pre-treatment with a high bolus dosage of Tirofiban (25 ìg/kg bolus)

2. No pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptoms of acute myocardial infarction of more than 30 minutes; 2. ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more. Ability to perform PCA within 6 hours after onset of symptoms.

Exclusion criteria

Exclusion criteria: 1. Patient with a contraindication to anticoagulation: a. Present bleeding disorder including gastrointestinal bleeding, hematuria, or known presence of occult blood in the stool prior to randomization. b. Systolic blood pressure persistently exceeding 200 mm Hg and/or diastolic blood pressure exceeding 110 mm Hg at time of enrollment. c. Recent (<6 mnd) Stroke or Transient Ischemic Attack; 2. Patients with severe renal failure (hemodialysis); 3. Patient with recent (< 30 days) major surgery; 4. Participation in another clinical study one year before enrollment.

Design outcomes

Primary

Measure	Time frame
To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban 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 of Clopidogrel).	—

Secondary

Measure	Time frame
1. To investigate the effect of upfront pre-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 (besides Aspirin, Heparin and 600 mg of Clopidogrel); 2. To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban on the incidence of normal myocardial perfusion as assessed by Myocardial Blush Grade scoring immediately after primary angioplasty, compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel); 3. To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban on infarct size as assessed by a single cTnT measurement performed 48-72 hours after Primary Coronary Angioplasty for acute myocardial infarction, compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel); 4. To investigate the effect of upfront pre-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 (besides Aspirin, Heparin and 600 mg of Clopidogrel); 5. To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban on the incidence of major bleeding (according to the most recent TIMI criteria), compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel).	—

Measure

Time frame

1. To investigate the effect of upfront pre-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 (besides Aspirin, Heparin and 600 mg of Clopidogrel); 2. To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban on the incidence of normal myocardial perfusion as assessed by Myocardial Blush Grade scoring immediately after primary angioplasty, compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel); 3. To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban on infarct size as assessed by a single cTnT measurement performed 48-72 hours after Primary Coronary Angioplasty for acute myocardial infarction, compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel); 4. To investigate the effect of upfront pre-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 (besides Aspirin, Heparin and 600 mg of Clopidogrel); 5. To investigate the effect of upfront pre-treatment with a high bolus dosage of Tirofiban on the incidence of major bleeding (according to the most recent TIMI criteria), compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel).

—

Contacts

Public ContactJ. Klijn

Diagram B.V. Zwolle Dokter Stolteweg 96

j.klijn@diagram-zwolle.nl+31 (0)38 4262997

Outcome results