DyslipidemiasREMAINSNCT01245738
Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
An observational study of Dyslipidemias and Hypercholesterolemia, run by Merck Sharp & Dohme LLC.
Trial summary
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia
- How many people
- 635 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients experiencing their first acute coronary event who are admitted to participating tertiary cardiac care centers in India will potentially be eligible for the study.
Who may be able to join
- Currently admitted with a confirmed diagnosis of first acute coronary event (STEMI/NSTEMI/Unstable Angina)
- Access to medical records covering the entire study period, and availability of data required for the study
- Potential to collect blood sample within 24 hours of onset for symptoms
- Considered for initiation/maintenance/modification of statin therapy before discharge from hospital
- Willing to comply with the study requirements
Who cannot join
- Participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview
- Known inherited disorder of lipoprotein metabolism
- History of hypothyroidism, nephrotic syndrome, chronic alcoholism, Cushing syndrome
About this study
Official title: Dyslipidemia: REsidual and Mixed Abnormalities IN Spite of Statin Therapy: The Dyslipidemia REMAINS Study: A Multicenter, Prospective, Observational Study of Lipid Profiles and Treatment Patterns at Presentation and After 12 Weeks of Statin Therapy Among Indian Adults Presenting With First Coronary Event
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins. Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATP III).
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia, High LDL-C, Low HDL-C
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol (TC) Levels at First Acute Coronary Event
At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).
Measured: At hospital presentation (Day 1)
Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event
At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).
Measured: At hospital presentation (Day 1)
High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event
At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).
Measured: At hospital presentation (Day 1)
Triglycerides (TG) Levels at First Acute Coronary Event
At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).
Measured: At hospital presentation (Day 1)
Change From Baseline in TC Levels After Treatment
TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Measured: Baseline and at Week 12
Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins
LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Measured: Baseline and at Week 12
Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins
HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Measured: Baseline and at Week 12
Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins
TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.
Measured: Baseline and at Week 12
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Measured: Week 12
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Measured: Week 12
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Measured: Week 12
Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Measured: Week 12
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Measured: Week 12
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245738
- Sponsor's protocol ID
- 0000-204
- Other IDs
- CTRI/2013/02/003429
- Acronym
- REMAINS
- Status last verified
- Jan 2017
- First submitted
- 13 Aug 2010
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia: REsidual and Mixed Abnormalities IN Spite of Statin Therapy: The Dyslipidemia REMAINS Study: A Multicenter, Prospective, Observational Study of Lipid Profiles and Treatment Patterns at Presentation and After 12 Weeks of Statin Therapy Among Indian Adults Presenting With First Coronary Event
- ClinicalTrials.gov ID
- NCT01245738
- Acronym / sponsor ID
- REMAINS / 0000-204
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia, High LDL-C, Low HDL-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins. Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATP III).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing their first acute coronary event who are admitted to participating tertiary cardiac care centers in India will potentially be eligible for the study.
Key inclusion criteria (5 listed)
- Currently admitted with a confirmed diagnosis of first acute coronary event (STEMI/NSTEMI/Unstable Angina)
- Access to medical records covering the entire study period, and availability of data required for the study
- Potential to collect blood sample within 24 hours of onset for symptoms
- Considered for initiation/maintenance/modification of statin therapy before discharge from hospital
- Willing to comply with the study requirements
Key exclusion criteria (3 listed)
- Participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview
- Known inherited disorder of lipoprotein metabolism
- History of hypothyroidism, nephrotic syndrome, chronic alcoholism, Cushing syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Cholesterol (TC) Levels at First Acute Coronary Event
Time frame: At hospital presentation (Day 1)
At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).
Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event
Time frame: At hospital presentation (Day 1)
At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).
High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event
Time frame: At hospital presentation (Day 1)
At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).
Triglycerides (TG) Levels at First Acute Coronary Event
Time frame: At hospital presentation (Day 1)
At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).
Change From Baseline in TC Levels After Treatment
Time frame: Baseline and at Week 12
TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins
Time frame: Baseline and at Week 12
LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins
Time frame: Baseline and at Week 12
HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.
Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins
Time frame: Baseline and at Week 12
TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
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
The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias and Hypercholesterolemia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (TC) Levels at First Acute Coronary Event (time frame: At hospital presentation (Day 1)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.