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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01162902
First received: April 30, 2010
Last updated: December 15, 2013
Last verified: December 2013

April 30, 2010
December 15, 2013
September 2013
January 2015   (final data collection date for primary outcome measure)
Wall to lumen ratio of fundus vessel [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
Same as current
Complete list of historical versions of study NCT01162902 on ClinicalTrials.gov Archive Site
  • lipid parameter [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
  • Serum markers of inflammation [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    CRP
  • Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ] [ Designated as safety issue: No ]
    Measure of change of nitrate need
  • lipid parameter [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
  • Serum markers of inflammation [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
    Measurement of change in the level of IL-6, IL-10, CRP, and MMP-9
  • Exercise capacity [ Time Frame: baseline, 1 month, and 9 months ] [ Designated as safety issue: No ]
    Measurement of change of cardiopulmonary exercise capacity
  • Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ] [ Designated as safety issue: No ]
    Measure of change of nitrate need
Not Provided
Not Provided
 
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stable Angina
  • Drug: Diltiazem treated group
    Diltiazem 180mg for 9 months
  • Drug: Bisoprolol treated group
    Bisoprolol 5mg for 9 months
  • Drug: Candesartan treated group
    Candesartan 32mg for 9 months
  • Experimental: Diltiazem treated group
    Diltiazem 180mg treated group
    Intervention: Drug: Diltiazem treated group
  • Active Comparator: Bisoprolol treated group
    Bisoprolol 5mg treated group
    Intervention: Drug: Bisoprolol treated group
  • Active Comparator: Candesartan treated group
    Candesartan 32mg treated group
    Intervention: Drug: Candesartan treated group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
December 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact: Hae-Young Lee, MD, PhD 82-10-4528-6160 hylee612@snu.ac.kr
Contact: Hyo-Soo Kim, MD, PhD 82-2-2072-2226 hyosoo@snu.ac.kr
Korea, Republic of
 
NCT01162902
ABC Trial
Yes
Hyo-Soo, Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP