Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00148460
Eligibility Criteria:
Inclusion Criteria:
1. Age \>= 18 and \<= 75 years.
2. Asian origin.
3. Ischemic discomfort \>= 30 minutes in duration.
4. Onset of acute myocardial infarction (AMI) symptoms within 6 hours prior to randomization.
5. A twelve lead electrocardiogram (ECG) with one of the following:
* ST segment elevation \>= 0.1 mV in two or more limb leads; or
* \>= 0.2 mV in two or more contiguous precordial leads indicative of AMI.
6. Ability to give informed consent.
Exclusion Criteria:
1. Previous coronary artery bypass grafting (CABG) surgery.
2. Cardiogenic shock (e.g. systolic blood pressure \[SBP\] \< 90 mmHg).
3. Systolic blood pressure (SBP) \>= 180 mmHg and/or diastolic blood pressure (DBP) \>= 110 mmHg during current admission on one reliable measurement prior to randomization.
4. Inability to undergo cardiac catheterization.
5. Significant bleeding disorder either at present or within the past 6 months.
6. Major surgery, biopsy of a parenchymal organ, or significant trauma within 3 months.
7. Any minor head trauma and/or any other trauma that occurred after onset of current myocardial infarction.
8. Use of heparin, GPIIb/IIIa antagonists or other anticoagulants within the last 2 weeks.
9. Any known history of stroke or transient ischemic attack or central nervous system structural damage (i.e. neoplasm, aneurysm, intracranial surgery).
10. Prolonged cardiopulmonary resuscitation (\> 10 minutes) within 2 weeks.
11. Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing potential must have had a negative pregnancy test and must have used a medically accepted method of birth control (i.e. uterine device, surgical sterilisation, progestogens alone).
12. Previous treatment with TNK-tPA (tenecteplase).
13. Inability to follow protocol and comply with follow-up.
14. Drug abuse within the last year.
15. Participation in another clinical trial within the previous 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00148460
Study Brief:
Protocol Section:
NCT00148460