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

NCT03054467 | Unknown Phase 4 DMC

• 1 other identifier: SCARLET
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Overall summary score assessed by short form SAQ

  6 months

Secondary Outcomes (4)

• FMD of the brachial artery

  6 months

• The change of Coronary flow reserve (CFR) assessed in the dLAD using TTE

  6 months

• Angina frequency from the patient's diary

  6 months

• Measurements of circulating endothelial progenitor cells (EPCs)

  6 months

Study Arms (2)

CADUET 10mg-20mg

ACTIVE COMPARATOR

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

Drug: Caduet 10Mg-20Mg Tablet

NORVASC

ACTIVE COMPARATOR

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

Drug: NorvasC® 10 mg Tablets

Interventions

Caduet 10Mg-20Mg Tablet 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

CADUET 10mg-20mg

NorvasC® 10 mg Tablets 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead

MeSH Terms

Interventions

amlodipine, atorvastatin drug combination; Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 15, 2017
• Study Start: December 1, 2018
• Primary Completion: April 28, 2019
• Study Completion: April 28, 2019
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share