Effect of Fimasartan for Modification of Atheroma Vulnerability in DEFERred Coronary Disease (FIMA-DEFER)

NCT ID: NCT01384747

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2018-03-31

Brief Summary

• Fimasartan will be more beneficial in stabilizing the plaque vulnerability compared to control group in deferred coronary lesions.
• Fimasartan will be more beneficial in reducing total plaque volume compared to control group in deferred coronary lesions.
• Fimasartan will be more beneficial in reducing functional impairment of stenotic lesions (assessed by FFR:Fractional Flow Reserve) in deferred coronary lesions.

Detailed Description

Prospective, double-blind, randomized clinical study with enrollment of patients over at least 18 years of age who require coronary angiography for a clinical indication with hypertension defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg. Inclusion requires at least one deferred coronary lesion with 1) visually-estimated angiographic %diameter stenosis 20-50% or 2) %diameter stenosis >50% without any evidence of inducible ischemia. The target vessel for IVUS interrogation must not have undergone angioplasty (deferred lesion) nor have more than 50% luminal narrowing throughout a target segment. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 (Fimasartan 60-120 mg vs placebo). All subjects will be followed up at 1 year for serial VH-IVUS and conventional IVUS evaluation. Also, OCT sub-study will be performed in selected patients with lesions at least 20 mm distally located from coronary ostium. All patients will be blindly assigned to control and Fimasartan once daily as 1:1 ratio and are prescribed for 1year.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

Fimasartan

Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive.

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)

Placebo

Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)

Interventions

Fimasartan

60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)

Intervention Type: DRUG

Placebo

60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)

Intervention Type: DRUG

Other Intervention Names

Kanarb Tab.

Eligibility Criteria

Inclusion Criteria

1. Hypertensive patients (systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg) or medically treated hypertension with normal blood pressure who undergo coronary angiography with clinical indications

2. 18 < Age < 85

3. Patient who has received informed consent

4. at least one deferred coronary lesion with 1) visually-estimated angiographic %diameter stenosis 20-50% or 2) %diameter stenosis >50% without any evidence of inducible ischemia (FFR ≥ 0.8 or negative perfusion defect on thallium scan or negative treadmill test)

Exclusion Criteria

1. Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period

2. Planned performance of PCI or CABG in the target vessel or its branches containing the index

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

4. Stroke or resuscitated sudden death in the past 6 months

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

6. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer

7. 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

8. Significant renal disease manifested by serum creatinine > 1.5 mg/dL

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

10. Active hepatitis B or C or carrier

11. Hypotension (systolic blood pressure <90 mmHg)

12. Patients already taking ACE inhibitors or ARBs

13. Patients with STEMI requiring primary PCI

14. Patients pregnant or breast-feeding or child-bearing potential

15. Patients who are lack of intention for effective contraception

16. Patients with history of previous enrollment into a clinical trials within 3 months

17. Allergic or contraindicated to Angiotensin II antagonists

18. History of any arterial bypass or angioplastic intervention involving the target vessel

19. Luminal narrowing in the left main > 50% by visual inspection of angiogram

20. Visually-estimated angiographic reference segment diameter of <2.75mm or >4.0 mm

21. Presence of thrombus or complex plaque morphology in the target vessel that suggests a high likelihood of distal embolism

22. Severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems

23. Inappropriate for IVUS procedures. Vessel with thrombus (on GS-IVUS), moderate or severe calcification, angulation

24. Culprit vessel in AMI

25. RWMA (Regional Wall Motion Abnormality) or scar tissue in the territory subtended by the studied lesion

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Chonnam National University Hospital

Gwangju, , South Korea

Asan Medical Center

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

CVRF2011-03

Identifier Type: -

Identifier Source: org_study_id