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

• Status: Terminated
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung-Jung Park
• Collaborators: Boryung Pharmaceutical Co., Ltd; CardioVascular Research Foundation, Korea

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