Ongoing 2b/3a inhibition In Myocardial infarction Evaluation
| ISRCTN | ISRCTN06195297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06195297 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 04/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J Klijn
Scientific
Scientific
Diagram B.V.
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
| Phone | +31 (0)38 4262997 |
|---|---|
| j.klijn@diagram-zwolle.nl |
Study information
| Study design | Multinational multicenter double-blind placebo-controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Ongoing 2b/3a inhibition In Myocardial infarction Evaluation |
| Study acronym | On-TIME 2 |
| Study objectives | 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). |
| Ethics approval(s) | Central Medical Ethics Review Committee (METC) of the Isala Ziekenhuizen of Zwolle (Netherlands) |
| Health condition(s) or problem(s) studied | Acute myocardial infarction |
| Intervention | 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) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tirofiban |
| Primary outcome measure | 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 measures | 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). |
| Overall study start date | 03/04/2004 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 950 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/04/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diagram B.V.
Zwolle
8011 NB
Netherlands
8011 NB
Netherlands
Sponsor information
Diagram B.V. (Netherlands)
Industry
Industry
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
"ROR" |
https://ror.org/03rhyyh86 |
|---|
Funders
Funder type
Industry
Merck Sharp & Dohme BV (MSD) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/08/2008 | Yes | No | |
| Results article | results | 01/06/2010 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No | |
| Results article | results | 01/05/2012 | Yes | No | |
| Other publications | subgroup analysis | 01/10/2017 | Yes | No | |
| Results article | results | 01/04/2019 | Yes | No |
Editorial Notes
04/01/2019: Publication reference added.
19/10/2017: Publication reference added.
