Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
1 other identifier
interventional
150
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2010
CompletedFirst Posted
Study publicly available on registry
July 15, 2010
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 17, 2013
December 1, 2013
1.3 years
April 30, 2010
December 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
lipid parameter
baseline, 9 months
Serum markers of inflammation
baseline, 9 months
Change of nitrate need
baseline, 1 months, and 3 months
Study Arms (3)
Diltiazem treated group
EXPERIMENTALDiltiazem 180mg treated group
Bisoprolol treated group
ACTIVE COMPARATORBisoprolol 5mg treated group
Candesartan treated group
ACTIVE COMPARATORCandesartan 32mg treated group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 30, 2010
First Posted
July 15, 2010
Study Start
September 1, 2013
Primary Completion
January 1, 2015
Study Completion
December 1, 2015
Last Updated
December 17, 2013
Record last verified: 2013-12