Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005493
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Observational Aspirin Use and CVD in the Physicians Health Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
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 analyze existing data from the Physicians Health Study PHS a randomized primary prevention trial of low-dose aspirin and beta carotene conducted among 22071 US male physicians to address questions concerning aspirin and cardiovascular CV disease that could not adequately be addressed during the randomized aspirin period
Detailed Description:
DESIGN NARRATIVE
The aspirin component of the trial was terminated on January 25 1988 due to a demonstrated benefit of aspirin on myocardial infarction At that time however the number of strokes and CV deaths experienced by trial participants was inadequate to definitively evaluate these endpoints The beta carotene component of the trial continued uninterrupted until its scheduled termination in December 1996 During this period detailed information continued to be collected on post-trial aspirin use through annual questionnaires As of October 1995 the number of deaths including cardiovascular deaths had increased fourfold from that in the randomized period and the number of strokes had increased 35 times The investigators used data from both the randomized aspirin period and the observational period following the trial to assess the impact of aspirin use on cardiovascular and total mortality and the long-term impact of aspirin use on subsequent stroke and MI The methods included analyses of both randomized aspirin assignment and of time-varying aspirin use as assessed on the annual questionnaires Because of the potential for bias the propensity for aspirin use particularly during the observational period was taken into account Analyses included use of proportional hazards models allowing for both time-varying effects of aspirin use and controlling for time-varying confounders as well as more complex procedures using causal modeling
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The aspirin component of the trial was terminated on January 25 1988 due to a demonstrated benefit of aspirin on myocardial infarction At that time however the number of strokes and CV deaths experienced by trial participants was inadequate to definitively evaluate these endpoints The beta carotene component of the trial continued uninterrupted until its scheduled termination in December 1996 During this period detailed information continued to be collected on post-trial aspirin use through annual questionnaires As of October 1995 the number of deaths including cardiovascular deaths had increased fourfold from that in the randomized period and the number of strokes had increased 35 times The investigators used data from both the randomized aspirin period and the observational period following the trial to assess the impact of aspirin use on cardiovascular and total mortality and the long-term impact of aspirin use on subsequent stroke and MI The methods included analyses of both randomized aspirin assignment and of time-varying aspirin use as assessed on the annual questionnaires Because of the potential for bias the propensity for aspirin use particularly during the observational period was taken into account Analyses included use of proportional hazards models allowing for both time-varying effects of aspirin use and controlling for time-varying confounders as well as more complex procedures using causal modeling
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| R03HL058476 | NIH | None | httpsreporternihgovquickSearchR03HL058476 |