Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Stable Angina Clinical Trial

Official title:

Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01162902
• Other study ID #: ABC Trial
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 30, 2010
• Last updated: December 15, 2013
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: Hae-Young Lee, MD, PhD
• Phone: 82-10-4528-6160
• Email: hylee612[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI

• Unstable Angina/NSTEMI patients who completed PCI for main lesions

• Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

• STEMI patients within one month

• Variant Angina

• Liver function abnormality or renal failure

• History of Hypersensitivity to testing drugs

• Severe heart failure(NYHA class>3) or uncorrectable hematologic disease

• Woman possible to be pregnant

• Uncontrolled diabetes

• Expected life span < one year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Drug:
• Diltiazem treated group
Diltiazem 180mg for 9 months
• Bisoprolol treated group
Bisoprolol 5mg for 9 months
• Candesartan treated group
Candesartan 32mg for 9 months

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wall to lumen ratio of fundus vessel	Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up	baseline, 9 months	No
Secondary	lipid parameter	Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL	baseline, 9 months	No
Secondary	Serum markers of inflammation	CRP	baseline, 9 months	No
Secondary	Change of nitrate need	Measure of change of nitrate need	baseline, 1 months, and 3 months	No