Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Coronary Vasospastic Angina

• Status: Unknown status
• Trial end date: 2019-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kosin University Gospel Hospital
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin Calcium

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.