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

NCT ID: NCT03054467

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-04-28

Brief 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.

Detailed Description

STUDY DESIGN Study protocol Study Start (expected FSFV (First subject first visit )) at August 1 2016 Study Stop (expected LSLV (Last subject last visit)) at February 29 2019 150 Patients with confirmed VSA who had over 3 episodes of angina per week during a over 2 week qualification period are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET. All other antianginal medications are proscribed during the study period except long-acting nitrates and sublingual nitroglycerin as required. Long-acting nitrates are permitted during the study period if they had been taken at a constant dosage for over 2 weeks before study entry. Participants are allowed to take sublingual NTG as needed for episodes of chest pain.

Study design. Patients with VSA who had over 1 angina episodes/week confirmed by ergonovine provocation test Acquisition of written consent Randomization to NORVASC 10 mg/day or CADUET 10/20 mg Baseline SAQ, angina diary, FMD, EPC, CFR assessments are performed. Medication start with either 5mg NORVASC or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, titrate to 10mg and 10/20mg CADUET. Routine visit with the scheduled reservation (2 or 3 months interval) After 6-months treatment, follow-up SAQ, angina diary, FMD, EPC, CFR assessments are performed (mandatory).

After 12-months treatment, follow-up SAQ, angina diary, FMD, EPC, CFR assessments are performed (optional).

Efficacy assessments. The primary efficacy variable is the change of summary score of SAQ-7 between NORVASC 10mg/day and CADUET 10/20mg, and the weekly average frequency of self-reported angina episodes during the 6-months treatment phase. Difference of Summary score of SAQ 7 is calculated between the baseline (at the enrollment before randomization) and the after 6-months treatment. The study staff at each clinical site will review the angina and nitroglycerin use diaries with the patient at each study visit.

Assessment of patient responses by short form SAQ at baseline and after 6 months treatment.

The Seattle Angina Questionnaire (SAQ) is a validated disease-specific instrument for assessing the health status of patients with coronary artery disease. Although the SAQ has been frequently used in clinical trials and registries, its use in routine clinical care has been limited by its length (19 questions) and the absence of a single summary score that facilitates an overall assessment of patients' health status.

Recently, 7-item from the Physical Limitation, Angina Frequency, and Quality of Life domains for the shortened version of the SAQ (SAQ 7), as well as an overall summary score was developed and validated in patients with stable coronary artery disease, undergoing percutaneous coronary intervention, and presenting with acute myocardial infarction.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CADUET 10mg-20mg

Patients are assigned to receive either amlodipine therapy (NORVASC 10 mg/day) for 6 months.

Group Type: ACTIVE_COMPARATOR

Caduet 10Mg-20Mg Tablet

Intervention Type: DRUG

Patients are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET

NORVASC

Patients are assigned to receive amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months

Group Type: ACTIVE_COMPARATOR

NorvasC® 10 mg Tablets

Intervention Type: DRUG

Patients are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET

Interventions

Caduet 10Mg-20Mg Tablet

Patients are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET

Intervention Type: DRUG

NorvasC® 10 mg Tablets

Patients are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kosin University Gospel Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyoung Im Cho

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SCARLET

Identifier Type: -

Identifier Source: org_study_id