Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Coronary Vasospastic Angina (NCT03054467) | Clinical Trial Compass
UnknownPhase 4
Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Coronary Vasospastic Angina
150 participantsStarted 2018-12-01
Plain-language summary
The aim of the present study is to compare the effects of CCB and CCB+ high dose of statin therapy on the symptoms, function, and quality of life assessed by validated angina-specific questionnaire (Short-form Seattle Angina Questionnaire (SAQ-7)), endothelial function as measured by FMD of the brachial artery, endothelial progenitor cells (EPC) and coronary flow reserve (CFR) in patients with VSA.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 be…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.