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:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT01356992
Eligibility Criteria:
Inclusion Criteria:
* ICF signature;
* The research subject must agree about following all instructions and perform the procedures and study visits;
* Men and women over the age of 18 and below the age of 75;
* History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days.
* Patient Randomization up to 6 hours after the arrival at the emergency sector.
* Evidence of NSTEMI or unstable angina due to one or more of the following criteria:
1\. Dynamic alterations on the T-wave (ST-segment depression or elevation \> 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or 2. Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or 3. Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or 5. Pulmonary Edema; or 6. Angina associated to murmur of mitral regurgitation; or 7. Angina with heart sound to cardiac auscultation or throes; or 8. Angina with hypotension;
Exclusion Criteria:
* 12-derivation-ECG with persistent ST-segment elevation;
* Diagnosis of angina by secondary cause (e.g., anemia, fever, hypovolemia, dehydration, use of cocaine);
* Use of non-fractionated heparin or low-molecular weight heparin in the prior 48 to the randomization;
* Concomitant diseases, such as severe renal failure (creatinine clearance lower than 30ml/min.) and hepatic, or other significant comorbidities under investigator judgment;
* Recent hemorrhagic cerebrovascular accident (last 12 months);
* Patient scheduled for cardiac surgery of myocardial revascularization;
* Use of drugs, alcohol abuse;
* Pregnancy or lactation;
* Recent neurosurgery or ophthalmic surgery (last 3 months);
* History or diagnosis of coagulopathy;
* Medical record containing allergy, hypersensibility or intolerance to any of the drug components to be used on this study, which is judged as clinically significant in the main investigator's opinion;
* Recent participation (last 12 months) in a clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01356992
Study Brief:
Protocol Section:
NCT01356992