Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft
Stress CABG
Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery
1 other identifier
interventional
400
1 country
1
Brief Summary
Depression is frequently observed in patients with coronary heart disease (CHD) and represents a significant risk factor for major cardiovascular events. Previous study has proved that high sensitive C-reactive protein (hsCRP) was an independent predictor for depression in CABG patients at 6 months after bypass surgery. Statins can effectively reduce the blood levels of hsCRP. This study aim to examine whether statins can improve the prognosis of depressive patients undergoing coronary artery bypass surgery through reducing the levels of hsCRP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2012
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
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 17, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 15, 2013
May 1, 2012
1.5 years
June 17, 2012
August 13, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Depression
The Hamilton Depression Rating Scale (HDRS) scores
1 month after surgery
General health status
36-Item Short-From Health Survey (SF-36) scores
1 month after surgery
Secondary Outcomes (1)
MACE
6 month
Study Arms (2)
control group
PLACEBO COMPARATORPlacebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
statin group
ACTIVE COMPARATORRosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month
Interventions
Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
Eligibility Criteria
You may qualify if:
- Hospitalized patients for coronary artery bypass graft surgery
You may not qualify if:
- Previous CABG surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhe Zheng, M.D., Ph.D.
China National Center for Cardiovascular Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2012
First Posted
June 21, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Study Completion
June 1, 2014
Last Updated
August 15, 2013
Record last verified: 2012-05