- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054467
Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Coronary Vasospastic Angina (SCARLET)
Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Symptoms, Function, and Quality of Life in Patients With Coronary Vasospastic Angina
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CADUET 10mg-20mg
Patients are assigned to receive either amlodipine therapy (NORVASC 10 mg/day) for 6 months.
|
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
|
Active Comparator: NORVASC
Patients are assigned to receive amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall summary score assessed by short form SAQ
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FMD of the brachial artery
Time Frame: 6 months
|
6 months
|
The change of Coronary flow reserve (CFR) assessed in the dLAD using TTE
Time Frame: 6 months
|
6 months
|
Angina frequency from the patient's diary
Time Frame: 6 months
|
6 months
|
Measurements of circulating endothelial progenitor cells (EPCs)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Angina, Unstable
- Angina Pectoris
- Angina Pectoris, Variant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Amlodipine
Other Study ID Numbers
- SCARLET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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