Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000555
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Womens Angiographic Vitamin and Estrogen Trial WAVE
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:
2005-08
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 assess whether hormonal replacement therapy andor antioxidant treatment would stabilize or inhibit progression and induce regression of coronary plaques The mechanisms by which these treatments modified atherosclerosis in women were also explored
Detailed Description:
BACKGROUND
Coronary artery disease is the leading cause of death in the United States accounting for over 500000 deaths each year Although the onset of coronary artery disease is delayed in women it is the single most important cause of death in women over the entire life span Indeed because more women than men survive to old age mortality due to coronary artery disease for all ages combined is as great in women as in men Furthermore once they present with clinical evidence of coronary artery disease women have a prognosis as poor as or even worse than that for men In part this may be due to late recognition of coronary artery disease in women less intensive treatment of women or a more adverse risk profile in women who develop coronary artery disease The report of a recent Working Group on Angiographic Trials of Atherosclerosis Prevention notes that compared to males females who develop coronary artery disease have various different characteristics which may affect the vascular response to lipid-altering interventions These differences led the report to question whether the mechanisms and clinical benefits of lipid-altering agents may be different in men and women It further noted that angiographic trials conducted to date have been based primarily upon the cholesterol-lowering treatments of diet or drugs and suggested that other approaches based upon the lipid hypothesis could profitably be tested and should be given the highest priority at this time specifically recommended were trials of hormone replacement and antioxidant therapy in women
DESIGN NARRATIVE
Subjects were randomized into a 2 x 2 factorial trial of hormone replacement therapy and antioxidant therapy Women were randomized into four treatment groups both active hormone replacement and antioxidant active hormone replacement therapy and antioxidant placebo active antioxidant therapy and hormone replacement placebo double placebo plus usual care Hormone replacement therapy consisted of estrogen plus a progestin PremPro for all gynecologically intact women and unopposed estrogen Premarin for women with hysterectomies Antioxidants consisted of a combination of vitamin E and vitamin C Angiographic change was a primary endpoint of this trial The study was double-blind to the extent permitted by the interventions however it was fully-blinded with respect to outcome variables Recruitment ended in August 1999 The mean duration of follow-up was approximately three years
The NHLBI awarded R01HL68397 in April 2001 as an ancillary study to WAVE The study entitled Modifying Oxidative Damage in WAVE has its on site on this database
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Coronary artery disease is the leading cause of death in the United States accounting for over 500000 deaths each year Although the onset of coronary artery disease is delayed in women it is the single most important cause of death in women over the entire life span Indeed because more women than men survive to old age mortality due to coronary artery disease for all ages combined is as great in women as in men Furthermore once they present with clinical evidence of coronary artery disease women have a prognosis as poor as or even worse than that for men In part this may be due to late recognition of coronary artery disease in women less intensive treatment of women or a more adverse risk profile in women who develop coronary artery disease The report of a recent Working Group on Angiographic Trials of Atherosclerosis Prevention notes that compared to males females who develop coronary artery disease have various different characteristics which may affect the vascular response to lipid-altering interventions These differences led the report to question whether the mechanisms and clinical benefits of lipid-altering agents may be different in men and women It further noted that angiographic trials conducted to date have been based primarily upon the cholesterol-lowering treatments of diet or drugs and suggested that other approaches based upon the lipid hypothesis could profitably be tested and should be given the highest priority at this time specifically recommended were trials of hormone replacement and antioxidant therapy in women
DESIGN NARRATIVE
Subjects were randomized into a 2 x 2 factorial trial of hormone replacement therapy and antioxidant therapy Women were randomized into four treatment groups both active hormone replacement and antioxidant active hormone replacement therapy and antioxidant placebo active antioxidant therapy and hormone replacement placebo double placebo plus usual care Hormone replacement therapy consisted of estrogen plus a progestin PremPro for all gynecologically intact women and unopposed estrogen Premarin for women with hysterectomies Antioxidants consisted of a combination of vitamin E and vitamin C Angiographic change was a primary endpoint of this trial The study was double-blind to the extent permitted by the interventions however it was fully-blinded with respect to outcome variables Recruitment ended in August 1999 The mean duration of follow-up was approximately three years
The NHLBI awarded R01HL68397 in April 2001 as an ancillary study to WAVE The study entitled Modifying Oxidative Damage in WAVE has its on site on this database
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 |
|---|---|---|---|
| N01HV68170 | NIH | None | None |
| N01HV68167 | NIH | None | None |
| N01HV68168 | NIH | None | None |
| N01HV68169 | NIH | None | None |
| N01HV68165 | NIH | None | None |
| N01HV68166 | NIH | None | None |