Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005389
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2000-05-25
Brief Title:
Effect of Drug Therapy on Reinfarction Risk in Women
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety of calcium-channel blockers in the secondary prevention of myocardial infarction in women
Detailed Description:
BACKGROUND
Research on heart disease in the 196Os and 197Os was primarily concerned with risk factors for premature atherosclerosis which was most dramatically apparent in working middle-aged men who suffered heart attacks or died suddenly This focus on premature disease was an important initial step but it resulted in a relative neglect of studies in older adults and in all women Coronary heart disease remains nonetheless a major cause of morbidity and mortality among women
Given the consistent findings from clinical trials that calcium-channel blockers administered following myocardial infarction do not decrease the risk of death or reinfarction and that some drugs of this class may actually increase the risk it is unlikely that future trials of this therapy in women will be conducted Yet the calcium-channel blockers are used with increasing frequency in women following myocardial infarction The only ethical method of conducting studies of the safety of these drugs in women is through observational studies Data from the study can help to guide clinical practice and can assist in the design of appropriate secondary prevention trials in women
DESIGN NARRATIVE
On-going studies of hormone-replacement therapy in women at Group Health Cooperative of Puget Sound GHC identified all female enrollees who suffered a first heart attack since 1986 the study expanded this inception cohort through 1996 Information from medical record review and GHC databases were used to assess risk factors and co-morbid conditions both at entry into the cohort and up to ten years of follow-up and to identify recurrent cardiovascular events and deaths A complete record of prescription drug exposure during the follow-up period was obtained for each subject from the GHC computerized pharmacy database Although the main hypothesis related to reinfarction risk in women men were studied as well to facilitate comparison of the results of this observational study with those of the clinical trials According to conservative estimates of the available sample size the investigators had 86 percent power to detect a relative risk of 145 in women alone and 85 percent power to detect a relative risk of 125 in men and women combined for the association of calcium-channel blocker use with fatal or non-fatal reinfarction The study also examined the safety and efficacy of other cardiovascular drugs commonly used in women after myocardial infarction including angiotensin converting-enzyme inhibitors lipid-lowering drugs and estrogen replacement therapy
Research on heart disease in the 196Os and 197Os was primarily concerned with risk factors for premature atherosclerosis which was most dramatically apparent in working middle-aged men who suffered heart attacks or died suddenly This focus on premature disease was an important initial step but it resulted in a relative neglect of studies in older adults and in all women Coronary heart disease remains nonetheless a major cause of morbidity and mortality among women
Given the consistent findings from clinical trials that calcium-channel blockers administered following myocardial infarction do not decrease the risk of death or reinfarction and that some drugs of this class may actually increase the risk it is unlikely that future trials of this therapy in women will be conducted Yet the calcium-channel blockers are used with increasing frequency in women following myocardial infarction The only ethical method of conducting studies of the safety of these drugs in women is through observational studies Data from the study can help to guide clinical practice and can assist in the design of appropriate secondary prevention trials in women
DESIGN NARRATIVE
On-going studies of hormone-replacement therapy in women at Group Health Cooperative of Puget Sound GHC identified all female enrollees who suffered a first heart attack since 1986 the study expanded this inception cohort through 1996 Information from medical record review and GHC databases were used to assess risk factors and co-morbid conditions both at entry into the cohort and up to ten years of follow-up and to identify recurrent cardiovascular events and deaths A complete record of prescription drug exposure during the follow-up period was obtained for each subject from the GHC computerized pharmacy database Although the main hypothesis related to reinfarction risk in women men were studied as well to facilitate comparison of the results of this observational study with those of the clinical trials According to conservative estimates of the available sample size the investigators had 86 percent power to detect a relative risk of 145 in women alone and 85 percent power to detect a relative risk of 125 in men and women combined for the association of calcium-channel blocker use with fatal or non-fatal reinfarction The study also examined the safety and efficacy of other cardiovascular drugs commonly used in women after myocardial infarction including angiotensin converting-enzyme inhibitors lipid-lowering drugs and estrogen replacement therapy
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL053375 | NIH | None | httpsreporternihgovquickSearchR01HL053375 |