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See also:
All cardiovascular prevention clinical trials
All clinical trials of antioxydants
All clinical trials of combination
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Treatments
Studied treatment |
multivitamins (30,000 IU of beta carotene, 500 mg of vitamin C, and 700 IU of vitamin E) for four weeks before and six months after angioplasty
|
Control treatment |
placebo
|
Remarks |
factorial design: probucol and multivitamins |
Patients
Patients |
patient undergoing angioplasty |
Inclusion criteria |
scheduled to undergo standard balloon angioplasty on at least one native coronary artery and had at least one target lesion with stenosis of 50 percent or more of the luminal diameter as measured by calipers on the angiogram |
Exclusion criteria |
unable to participate in the pretreatment evaluation or unable to return for follow-up; myocardial infarction within the previous seven days; scheduled to undergo stenting or atherectomy; prior angioplasty for another lesion in the preceding six months; treatement for a restenotic lesion; angioplasty of a bypass graft or of a bypassed native vessel with a patent graft |
Method and design
Randomized effectives |
158 / 159 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double-blind |
Follow-up duration |
6 montsh |
Premature discontinuation |
Premature discontinuation for efficacy |
Number of centre |
single center |
Geographic area |
Canada |
Hypothesis |
Superiority |
Primary endpoint |
extent of restenosis |
Remarks / Comments
premature stopping for efficacy of probucol
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
2 / 158
3 / 159
classic
0,67 [0,11;3,96]
All cause death
1 / 158
1 / 159
classic
1,01 [0,06;15,95]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
2 / 158 (1,3%) |
3 / 159 (1,9%) |
0,67 |
[0,11;3,96] |
MI |
13137 |
All cause death
|
1 / 158 (0,6%) |
1 / 159 (0,6%) |
1,01 |
[0,06;15,95] |
|
13137 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
13137: Tardif JC, C�t� G, Lesp�rance J, Bourassa M, Lambert J, Doucet S, Bilodeau L, Nattel S, de Guise PProbucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group.N Engl J Med 1997;337:365-72
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
1,27% |
1,89% |
-6,2‰
|
All cause death |
6,33‰ |
6,29‰ |
0,0‰
|
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for secondary prevention
antioxydants in cardiovascular prevention for all type of patients
Reference(s)
-
Tardif JC, C�t� G, Lesp�rance J, Bourassa M, Lambert J, Doucet S, Bilodeau L, Nattel S, de Guise P.
Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group..
N Engl J Med 1997;337:365-72
Pubmed
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Hubmed
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