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| Ongoing 2b/3a inhibition In Myocardial infarction Evaluation |
| ISRCTN | ISRCTN06195297 |
| ClinicalTrials.gov identifier | |
| Public title | Ongoing 2b/3a inhibition In Myocardial infarction Evaluation |
| Scientific title | |
| Acronym | On-TIME 2 |
| Serial number at source | N/A |
| Study hypothesis |
Primary:
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). |
| Lay summary | Not provided at time of registration |
| Ethics approval | Approved by the central Medical Ethics Review Committee (METC) of the Isala Ziekenhuizen of Zwolle (Netherlands) |
| Study design | Multinational, multicenter, double-blind, placebo-controlled, randomised |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Acute myocardial infarction |
| Participants - 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 3. Ability to perform PCA within 6 hours after onset of symptoms |
| Participants - 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 randomisation b. Systolic blood pressure persistently exceeding 200 mm Hg and/or diastolic blood pressure exceeding 110 mm Hg at time of enrolment c. Recent (<6 mnd) Stroke or Transient Ischemic Attack 2. Patients with severe renal failure (hemodialysis) 3. Patient with recent (< 30 days) major surgery Participation in another clinical study one year before enrolment |
| Anticipated start date | 03/04/2004 |
| Anticipated end date | 01/01/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 950 |
| 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) |
| Primary outcome measure(s) | 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 outcome measure(s) |
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). |
| Sources of funding | Merck Sharp & Dohme BV (MSD) (Germany) |
| Trial website | http://www.diagram-zwolle.nl |
| Publications |
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18707985
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20510211 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22162050 4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21744314 |
| Contact name | Dr J Klijn |
| Address |
Diagram B.V.
Van Nahuysplein 6 |
| City/town | Zwolle |
| Zip/Postcode | 8011 NB |
| Country | Netherlands |
| Tel | +31 (0)38 4262997 |
| Fax | +31 (0)38 4262990 |
| j.klijn@diagram-zwolle.nl | |
| Sponsor | Diagram B.V. (Netherlands) |
| Address | Van Nahuysplein 6 |
| City/town | Zwolle |
| Zip/Postcode | 8011 NB |
| Country | Netherlands |
| Date applied | 12/09/2005 |
| Last edited | 21/12/2011 |
| Date ISRCTN assigned | 12/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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