See also:

SPARCL study, 2006	TRC4661
[NCT00147602]	download pdf: atorvastatin | cholesterol lowering intervention for post stroke

Treatments

Studied treatment	atorvastatin 80mg daily
Control treatment	placebo

Patients

Patients	patients who had had a stroke or TIA within one to six months before study entry, had low-density lipoprotein (LDL) cholesterol levels of 2.6 to 4.9 mmol per liter, and had no known coronary heart disease
Baseline characteristics	Age, yr 62.7  male (%) 59.6  stroke as entry event (%) 69.1  TIA as entry event (%) 30.9  Time since entry event, days 85.7  baseline total cholesterol (mg/dL) 211.9  baseline LDL cholesterol (mg/dl) 133.2  baseline HDL cholesterol (mg/dl) 50  baseline triglyceridess (mg/dl) 143.7

Method and design

Randomized effectives	2365 / 2366 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	4.9y (median)
Lost to follow-up	0.53%
Hypothesis	Superiority
Primary endpoint	nonfatal or fatal stroke

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Fatal stroke

24 / 2365
41 / 2366
0,59 [0,36;0,97]

cardiovascular events

334 / 2365
407 / 2366
0,82 [0,72;0,94]

Non fatal stroke

247 / 2365
280 / 2366
0,88 [0,75;1,04]

Coronary event

81 / 2365
120 / 2366
0,68 [0,51;0,89]

Cardiovascular death

78 / 2365
98 / 2366
0,80 [0,59;1,07]

stroke (fatal and non fatal)

265 / 2365
311 / 2366
0,85 [0,73;0,99]

TIA

153 / 2365
208 / 2366
0,74 [0,60;0,90]

All cause death

216 / 2365
211 / 2366
1,02 [0,85;1,23]

stroke or TIA

375 / 2365
476 / 2366
0,79 [0,70;0,89] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Fatal stroke	24 / 2365 (1,0%)	41 / 2366 (1,7%)	0,59	[0,36;0,97]
cardiovascular events	334 / 2365 (14,1%)	407 / 2366 (17,2%)	0,82	[0,72;0,94]
Non fatal stroke	247 / 2365 (10,4%)	280 / 2366 (11,8%)	0,88	[0,75;1,04]
Coronary event	81 / 2365 (3,4%)	120 / 2366 (5,1%)	0,68	[0,51;0,89]
Cardiovascular death	78 / 2365 (3,3%)	98 / 2366 (4,1%)	0,80	[0,59;1,07]
stroke (fatal and non fatal)	265 / 2365 (11,2%)	311 / 2366 (13,1%)	0,85	[0,73;0,99]
TIA	153 / 2365 (6,5%)	208 / 2366 (8,8%)	0,74	[0,60;0,90]
All cause death	216 / 2365 (9,1%)	211 / 2366 (8,9%)	1,02	[0,85;1,23]
stroke or TIA	375 / 2365 (15,9%)	476 / 2366 (20,1%)	0,79	[0,70;0,89]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 4.9y (median))
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Fatal stroke	1,01%	1,73%	-0,72%
cardiovascular events	14,12%	17,20%	-3,08%
Non fatal stroke	10,44%	11,83%	-1,39%
Coronary event	3,42%	5,07%	-1,65%
Cardiovascular death	3,30%	4,14%	-0,84%
stroke (fatal and non fatal)	11,21%	13,14%	-1,94%
TIA	6,47%	8,79%	-2,32%
All cause death	9,13%	8,92%	0,22%
stroke or TIA	15,86%	20,12%	-4,26%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for post stroke (or TIA)

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in post stroke for all type of patients

Reference(s)

TrialResults-center ID	TRC4661
Trials register #	NCT00147602
Study web site link	http://www.strokecenter.org/trials/TrialDetail.aspx?tid=67

• Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA. High-dose atorvastatin after stroke or transient ischemic attack.. N Engl J Med 2006 Aug 10;355:549-59
  Pubmed | Hubmed | Fulltext
• Amarenco P, Benavente O, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, Gilbert S, Rudolph AE, Simunovic L, Zivin JA, Welch KM. Results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial by stroke subtypes.. Stroke 2009;40:1405-9
  Pubmed | Hubmed | Fulltext

(c) 2004-2016 TrialResults-center - All Rights Reserved