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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2013/02/003429 | Registry Identifier | CTRI |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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. | Baseline and at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
635 participants were considered eligible for the study, however; only 514 started (had complete baseline data).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants who had a total cholesterol measurement at baseline. | Posted | Mean | Standard Deviation | mg/dL | At hospital presentation (Day 1) |
|
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Up to 12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 12 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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). | Participants who had a LDL-C measurement at baseline. | Posted | Mean | Standard Deviation | mg/dL | At hospital presentation (Day 1) |
|
|
|
| Primary | 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). | Participants who had a HDL-C measurement at baseline. | Posted | Mean | Standard Deviation | mg/dL | At hospital presentation (Day 1) |
|
|
|
| Primary | 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). | Participants who had a TG measurement at baseline. | Posted | Mean | Standard Deviation | mg/dL | At hospital presentation (Day 1) |
|
|
|
| Primary | 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. | Participants of the Full Analysis Set (FAS) Population who had a TC measurements at baseline and Week 12. | Posted | Mean | Standard Deviation | mg/dL | Baseline and at Week 12 |
|
|
|
| Primary | 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. | Participants of the FAS Population who had LDL-C measurements at baseline and Week 12. | Posted | Mean | Standard Deviation | mg/dL | Baseline and at Week 12 |
|
|
|
| Primary | 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. | Participants of the FAS Population who had HDL-C measurements at baseline and Week 12. | Posted | Mean | Standard Deviation | mg/dL | Baseline and at Week 12 |
|
|
|
| Primary | 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. | Participants of the FAS Population who had TG measurements at baseline and Week 12. | Posted | Mean | Standard Deviation | mg/dL | Baseline and at Week 12 |
|
|
|
| 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 | 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. | Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements at Week 12. | Posted | Number | Percentage of Participants | Week 12 |
|
|
|
| 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 | 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. | Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12. | Posted | Number | Percentage of Participants | Week 12 |
|
|
|
| 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 | 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. | Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12. | Posted | Number | Percentage of Participants | Week 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 | 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. | Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12. | Posted | Number | Percentage of Participants | Week 12 |
|
|
|
| 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 | 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. | Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12. | Posted | Number | Percentage of Participants | Week 12 |
|
|
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| 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 | 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. | Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12. | Posted | Number | Percentage of Participants | Week 12 |
|
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|
| 6 |
| 474 |
| 0 |
| 474 |
| Myocardial Infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Sensory Disturbance | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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The scientific information generated from this study will be publically disclosed in forms of peer reviewed publication and scientific presentations and may even be actively disseminated amongst the practicing medical community in appropriate scientific platforms.