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


- candidate number0
- NTR NumberNTR74
- ISRCTNISRCTN06195297
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR3-aug-2005
- Secondary IDsN/A 
- Public TitleOngoing 2b/3a inhibition In Myocardial infarction Evaluation.
- Scientific TitleA 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.
- ACRONYMOn-TIME 2
- hypothesisPrimary:
Upfront pre-treatment with a high bolus dosage of Tirofiban will result in a lower 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:
1. Upfront pre-treatment with a high bolus dosage of Tirofiban will result in a higher 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. Upfront pre-treatment with a high bolus dosage of Tirofiban will result in a higher incidence of normal myocardial perfusion as assessed by Myocardial Blush Grade scoring on immediately after primary angioplasty, compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel).
3. Upfront pre-treatment with a high bolus dosage of Tirofiban will result in a smaller 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. Upfront pre-treatment with a high bolus dosage of Tirofiban will result in a lower 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. Upfront pre-treatment with a high bolus dosage of Tirofiban will not result in a higher incidence of major bleeding (according to the most recent TIMI criteria), compared to no pre-treatment (besides Aspirin, Heparin and 600 mg of Clopidogrel).
- Healt Condition(s) or Problem(s) studiedAcute myocardial infarction
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-apr-2004
- planned closingdate1-jan-2007
- Target number of participants950
- Interventions1. 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).
- Primary outcomeTo 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 outcome1. 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).
- TimepointsN/A
- Trial web sitehttp://www.diagram-zwolle.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES J. Klijn
- CONTACT for SCIENTIFIC QUERIESMD. PhD. A.W.J. Hof, van 't
- Sponsor/Initiator Merck Sharp & Dohme BV (MSD) Germany, Diagram B.V.
- Funding
(Source(s) of Monetary or Material Support)
Merck Sharp & Dohme BV (MSD), Germany
- PublicationsN/A
- Brief summaryPossible other participating centres: br> The Netherlands:
UMCG Groningen, Dpt of Cardiology, Dr. F. Zijlstra, MD, PhD.;
Germany:
Klinikum Schweinfurt, Dpt of Cardiology, Prof. Seggewiss;
Klinikum Coburg, Dpt of Cardiology, Prof. Brachmann;
Städstische Kliniken a.N. Esslingen, Dpt od Cardiologie, Prof. Leschke;
Herzzentrum Bad Krozingen, Prof. Neumann;
Klinikum Lüdenscheid. Dpt of Cardiology, Dr. Lemke, MD, PhD;
Klinikum Krefeld, Dpt of Cardiology, Prof. Späh;
Evangelisches Krankenhaus Düsseldorf, Dpt of Cardiology, Prof. Vester;
Kliniken der Ruhr-Universität Bochum, Dpt Cardiology, Prof. Mügge;
Essener Herzinfarktverbund, 4 Essener Kliniken;
Der Charité - Universitätsmedizin Berlin, Dpt of Cardiology, Dr. Möckel MD, PhD. (Dr. Dwäre MD, PHD.);
Städtisches Klinikum Kiel, Dpt of Cardiology, Prof. Buchwald;
Universitätsklinikum Lübeck, Dpt of Cardiology, Prof. Schunkert;
Herzzentrum Brandenburg in Bernau, Dr. Butter, MD, PhD;
Universitätsklinikum Röstock, Dpt of Cardiology, Prof. Nienaber;
Belgium:
CHR de la Citadelle Liège, Dpt of Cardiology, Dr. Jean Boland;
Poland:
University Hospital Poznan, Dpt of Cardiology, Dr. Lesiak, MD, PhD;
- Main changes (audit trail)
- RECORD9-aug-2005 - 19-okt-2009


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