| Trial ID: | L1402 |
| Source ID: | NCT02294643
|
| Associated Drug: |
Sarpogrelate
|
| Title: |
Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study
|
| Acronym: |
SERENADE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Coronary Artery Disease|Diabetes Mellitus|Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: Sarpogrelate|DRUG: Aspirin|DRUG: Clopidogrel|DRUG: Placebo (for Sarpogrelate)
|
| Outcome Measures: |
Primary: late lumen loss measured by quantitative coronary angiography, 9 months | Secondary: all cause deaths, 12 months|cardiac death, 12 months|nonfatal myocardial infraction, 12 months|target lesion revascularization, 12 months|major bleeding using the TMI bleeding classification, 12 months|hepatic impairments as measured by ncreased serum glutamyl oxaloacetic transaminase level or glutamyl pyruvic transaminase level increased more than threefold of the upper normal range, increased serum glutamyl oxaloacetic transaminase level or glutamyl pyruvic transaminase level increased more than threefold of the upper normal range, 12 months|renal impairments as measured by increased microalbuminuria or decreased creatinine clearance, increased microalbuminuria or decreased creatinine clearance, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital | Collaborators: Yuhan Corporation
|
| Gender: |
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
220
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-04
|
| Completion Date: |
2014-03
|
| Results First Posted: |
|
| Last Update Posted: |
2014-11-25
|
| Locations: |
Seoul National University Bundang Hospital, Seongnam, 463-707, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02294643
|
