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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT03054467
Eligibility Criteria:
* The investigators include patients who are newly diagnosed with VSA within 3 months of the screening and patients without CCB during the 1month of screening.
* VSA patients who had over 3 episodes of angina per week during a over 2-week qualification period will be included.
* In addition to the angina symptoms, the following two criteria for diagnosing VSA needed to be satisfied:
* (1) spontaneous or ergonovine induced coronary artery spasm (producing over 90% narrowing of coronary lumen diameter during angiography) associated with chest pain and ischemic ST segment changes (transient ST elevation or depression over 0.1 mV, recorded from at least two contiguous leads on the 12-lead ECG);
* (2) normal or insignificant (diameter stenosis under 50%) coronary artery disease after intracoronary nitroglycerine injection.
* The investigators exclude patients who have fixed stenosis corresponding to ≥50% of the lumen diameter in the coronary artery and those who have a history of allergic reaction to amlodipine or atorvastatin.
* Other exclusion criteria are:
* (1) myocardial infarction within 3 months of screening;
* (2) history of life threatening events associated with previous episodes of coronary artery spasm, such as ventricular tachycardia, ventricular fibrillation, or syncopal episodes;
* (3) decompensated congestive heart failure;
* (4) significant valvular heart disease;
* (5) systolic blood pressure under 90 mm Hg;
* (6) baseline heart rate over 100 beats/min;
* (7) ECG abnormalities precluding interpretation of the ST changes;
* (8) coronary artery bypass surgery or percutaneous coronary intervention within 3 months of screening;
* (9) women of childbearing potential who refused to use contraception;
* (10) active hepatic or renal disease;
* (11) other major concomitant disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03054467
Study Brief:
Protocol Section:
NCT03054467