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Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204) (REMAINS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01245738
First received: August 13, 2010
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: August 8, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Dyslipidemias
Hypercholesterolemia
Hypertriglyceridemia
High LDL-C
Low HDL-C

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Data were collected at the time of the first acute coronary event and 12 weeks after post-event statin therapy among participants across 19 tertiary cardiac care centers in India.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
635 participants were considered eligible for the study, however; only 514 started (had complete baseline data).

Reporting Groups
  Description
Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.

Participant Flow:   Overall Study
    Participants  
STARTED     514  
COMPLETED     474  
NOT COMPLETED     40  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.

Reporting Groups
  Description
Participants Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.

Baseline Measures
    Participants  
Number of Participants  
[units: participants]
  474  
Age  
[units: Years]
Mean ± Standard Deviation
  54.2  ± 10.6  
Gender  
[units: Participants]
 
Female     94  
Male     380  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Cholesterol (TC) Levels at First Acute Coronary Event   [ Time Frame: At hospital presentation (Day 1) ]

2.  Primary:   Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event   [ Time Frame: At hospital presentation (Day 1) ]

3.  Primary:   High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event   [ Time Frame: At hospital presentation (Day 1) ]

4.  Primary:   Triglycerides (TG) Levels at First Acute Coronary Event   [ Time Frame: At hospital presentation (Day 1) ]

5.  Primary:   Change From Baseline in TC Levels After Treatment   [ Time Frame: Baseline and at Week 12 ]

6.  Primary:   Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins   [ Time Frame: Baseline and at Week 12 ]

7.  Primary:   Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins   [ Time Frame: Baseline and at Week 12 ]

8.  Primary:   Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins   [ Time Frame: Baseline and at Week 12 ]

9.  Primary:   Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins   [ Time Frame: Week 12 ]

10.  Primary:   Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins   [ Time Frame: Week 12 ]

11.  Primary:   Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins   [ Time Frame: Week 12 ]

12.  Primary:   Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins   [ Time Frame: Week 12 ]

13.  Primary:   Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins   [ Time Frame: Week 12 ]

14.  Primary:   Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01245738     History of Changes
Other Study ID Numbers: 0000-204, CTRI/2013/02/003429
Study First Received: August 13, 2010
Results First Received: August 8, 2014
Last Updated: August 8, 2014
Health Authority: India: Institutional Review Board