JPRN-UMIN000036721
Completed
Phase 4
Observation of Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring GuidAnce in Patients with Type 2 Diabetes MeLlitus: Near-infrared Spectroscopic Analaysis - OPTIMA
ational Cerebral & Cardiovascular Centre0 sites94 target enrollmentMay 15, 2019
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Cerebral & Cardiovascular Centre
- Enrollment
- 94
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •The main exclusion criteria are listed in Table 3\. Non\-culprit vessel with its severe tortuousty and/or calcification will be excluded due to the risk of NIRS/IVUS imaging. Subjects with baseline estimated glomerular filtration rate \<40 mL/min/1\.73m2, those without any atherosclerotic lesions in their non\-culprit vessels and patients who are taking or are scheduled to receive proprotein convertase subxilisin/kexin type 9 will not be eligible.
Outcomes
Primary Outcomes
Not specified
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Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN): A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease - SATURCoronary Atheroma -- The current trial will study patients who have a clinical indication for coronary catheterization and who have coronary artery disease.MedDRA version: 9.1Level: LLTClassification code 10011092Term: Coronary atheromaEUCTR2007-004000-13-BEAstraZeneca AB1,300