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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Symptoms, Function, and Quality of Life in Patients With Coronary Vasospastic Angina

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 Summary:

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/da
Sponsor: Kosin University Gospel Hospital

Current Primary Outcome: Overall summary score assessed by short form SAQ [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • FMD of the brachial artery [ Time Frame: 6 months ]
  • The change of Coronary flow reserve (CFR) assessed in the dLAD using TTE [ Time Frame: 6 months ]
  • Angina frequency from the patient's diary [ Time Frame: 6 months ]
  • Measurements of circulating endothelial progenitor cells (EPCs) [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Kosin University Gospel Hospital

Dates:
Date Received: February 12, 2017
Date Started: May 1, 2017
Date Completion: April 28, 2019
Last Updated: March 20, 2017
Last Verified: March 2017