Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02378064
• Date of registration: 26/02/2015
• Prospective Registration: Yes
• Primary sponsor: CHEOL WHAN LEE, M.D., Ph.D
• Public title: Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation FACE
• Scientific title: Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation
• Date of first enrolment: May 2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02378064
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or Women at least 18 years of age inclusive

- Patients with acute coronary syndromes or unstable angina pectoris

- Hypertension or blood pressure more than 140/90mmHg

- FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta

- The patient or guardian agrees to the study protocol and the schedule of clinical and
FDG PET/CT follow-up, and provides informed, written consent, as approved by the
appropriate Institutional Review Board/Ethical Committee of the respective clinical
site.

Exclusion Criteria:

- Patients treated with carotid endarterectomy or stent placement

- Chronic disease requiring treatment with oral, intravenous, or intra-articular
corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).

- Untreated hyperthyroidism, or hypothyroidism

- Any clinically significant abnormality identified at the screening visit, physical
examination, laboratory tests, or electrocardiogram which, in the judgment of the
Investigator, would preclude safe completion of the study.

- Evidence of congestive heart failure, or left ventricular ejection fraction < 40%.

- Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine
clearance of < 40 ml/min (by Cockcroft-Gault method).

- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation
(ALT or AST > 3 times upper limit of normal).

- History of adult asthma manifested by bronchospasm in the past 6 months, or currently
taking regular anti-asthmatic medication(s).

- Unwillingness or inability to comply with the procedures described in this protocol.

- Patient's pregnant or breast-feeding or child-bearing potential.

- Type I Diabetes



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Inflammation Plaque, Atherosclerotic

Coronary Disease

Renin-Angiotensin System

Intervention(s)

Drug: 6-month treatment

Primary Outcome(s)

change (follow-up minus baseline) in standardized FDG uptake value [Time Frame: 6month]

Secondary Outcome(s)

changes of blood pressure [Time Frame: 6month]

Serial changes of lipid battery [Time Frame: 6month]

Secondary ID(s)

AMCCV2014-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boryung Pharmaceutical Co., Ltd