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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT01863134
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have a typical anginal pain lasting at least 20 min., but no longer than 24h.
* ECG confirming ischaemia
* ST segment depression \>= 1,0 mm in at least 2 leads, or,
* negative T waves \>= 2,0 mm in at least 2 leads.
* Positive troponin I (TnI).
* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
* Subjects must be ≥ 21 year of age, of either sex and any race.
* Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD - intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
* Subjects must be free of any clinically significant disease that would interfere with study evaluations (see exclusion criteria).
* Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to record concomitant medications and adverse events.
Exclusion Criteria:
* Women who are pregnant or nursing.
* Subjects who have not observed the designated washout periods for any of the prohibited medications.
* Subjects who have used any investigational product within 30 days prior to enrollment.
* Subjects who have the following clinical conditions are excluded:
Patients with:
* Angina lasting longer than 24h.
* ST segment elevation - Pardy wave
* age over 75 years
* history of revascularization procedure during last 6 months (PTCA, CABG)
* chronic heart failure (NYHA III or IV) during pre-hospitalization period
* history of bleeding from gastrointestinal tract or genitourinary system during last 30 days
* history of intracranial lesions or stroke
* history of major surgery or trauma during last 6 weeks
* history of hemorrhagic diathesis
* thrombocytopenia \< 100 000/mm3
* anticoagulant therapy with INR\>2,0
* significant hepatic failure
* significant renal failure with serum creatinine\>2,0 mg%
* elevated blood pressure: SBP\>200mmHg and/or DBP\>110mmHg despite the antihypertensive treatment
* allergy to drugs or any therapeutic agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT01863134
Study Brief:
Protocol Section:
NCT01863134