Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000500
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
1999-10-27
Brief Title:
Physicians Health Study
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-01
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 assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and secondarily the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene
Detailed Description:
BACKGROUND
Thrombosis plays a major role in the late stages of coronary occlusion Platelet aggregation is a large component in the formation of arterial thrombi In pharmacologic studies aspirin has been shown to inhibit platelet aggregation and therefore might be expected to prevent coronary occlusion These effects are apparent in the dose range of l00-l000 mgday and may be most evident at l60 milligrams daily Higher doses seem to be no more effective in either inhibition of platelet agreeability or prolonged bleeding time
Although an early case-control study by Jick and Miettinen showed a large benefit most observational studies had shown a cardiovascular benefit of about 20 percent Conclusive data could only result from a randomized trial with a large sample size
DESIGN NARRATIVE
Randomized double-blind fixed sample Participants were randomized into one of four treatment groups one 325 milligram aspirin tablet every other day alternating with one 30 milligram capsule of beta-carotene one aspirin every other day alternating with one capsule of beta-carotene placebo one aspirin placebo tablet every other day alternating with one capsule of beta-carotene and one aspirin placebo tablet every other day alternating with one capsule of beta-carotene placebo Major endpoints for the cardiovascular component of the study were cardiovascular mortality total mortality and coronary events
Thrombosis plays a major role in the late stages of coronary occlusion Platelet aggregation is a large component in the formation of arterial thrombi In pharmacologic studies aspirin has been shown to inhibit platelet aggregation and therefore might be expected to prevent coronary occlusion These effects are apparent in the dose range of l00-l000 mgday and may be most evident at l60 milligrams daily Higher doses seem to be no more effective in either inhibition of platelet agreeability or prolonged bleeding time
Although an early case-control study by Jick and Miettinen showed a large benefit most observational studies had shown a cardiovascular benefit of about 20 percent Conclusive data could only result from a randomized trial with a large sample size
DESIGN NARRATIVE
Randomized double-blind fixed sample Participants were randomized into one of four treatment groups one 325 milligram aspirin tablet every other day alternating with one 30 milligram capsule of beta-carotene one aspirin every other day alternating with one capsule of beta-carotene placebo one aspirin placebo tablet every other day alternating with one capsule of beta-carotene and one aspirin placebo tablet every other day alternating with one capsule of beta-carotene placebo Major endpoints for the cardiovascular component of the study were cardiovascular mortality total mortality and coronary events
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 |
|---|---|---|---|
| R01HL034595 | NIH | None | httpsreporternihgovquickSearchR01HL034595 |