Evidence map›Paper›PMID 18753638›Full record

Trial reportThe New England journal of medicine2008

Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.

Ralph L Sacco, Hans-Christoph Diener, Salim Yusuf, Daniel Cotton, Stephanie Ounpuu, William A Lawton, Yuko Palesch, Reneé H Martin, Gregory W Albers, Philip Bath and 25 more

2 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 259 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
259citing papers in PubMed, 20 pooled it
54.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00153062 phase4completednot on this map

PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis

TypeinterventionalSponsorBoehringer IngelheimRan2003Enrolled20,332ConditionsStrokeArmsAggrenox, Clopidogrel placebo, Micardis, Aggrenox placebo, Clopidogrel
NCT00991029 phase3terminatednot on this mapstarted 2010, after this paper: background citation

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2010 to 2018Enrolled4,881ConditionsIschemic Attack, TransientArmsClopidogrel, placebo
3 · Its place in the literature

Who cites it

259 citing papers in PubMed, 20 syntheses or guidelines pooled it, 965 citations in OpenAlex.

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  18. Interventions for deliberately altering blood pressure in acute stroke.The Cochrane database of systematic reviews · 2014
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199 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

35 authors at 13 institutions in 9 countries.

Ralph L SaccoMiller School of Medicine, University of Miami, Miami, USA.
Hans-Christoph Diener
Salim Yusuf
Daniel Cotton
Stephanie Ounpuu
William A Lawton
Yuko Palesch
Reneé H Martin
Gregory W Albers
Philip Bath
Natan Bornstein
Bernard P L Chan
Sien-Tsong Chen
Luis Cunha
Björn Dahlöf
Jacques De Keyser
Geoffrey A Donnan
Conrado Estol
Philip Gorelick
Vivian Gu
Karin Hermansson
Lutz Hilbrich
Markku Kaste
Chuanzhen Lu
Thomas Machnig
Prem Pais
Robin Roberts
Veronika Skvortsova
Philip Teal
Danilo Toni
Cam Vandermaelen
Thor Voigt
Michael Weber
Byung-Woo Yoon
PRoFESS Study Group
Boehringer Ingelheim (Canada) · CAChang Gung Memorial Hospital · TWHospitais da Universidade de Coimbra · PTNational Academy of Medicine · USNational Stroke Foundation · AUNational University Hospital · SGPopulation Health Research Institute · CAStanford Medicine · USUniversity Medical Center Groningen · NLUniversity of British Columbia · CAUniversity of Miami · USUniversity of Nottingham · GBZhejiang Chint Electrics (China) · CN

Funding

Collateral Circulation in Acute Ischemic StrokeK23NS054084 · NINDS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LIEBESKIND, DAVID SIGMUND · 2006 to 2010
$764k
NINDS NIH HHS K23 NS054084
6 · The paper itself

Abstract

backgroundRecurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens--aspirin plus extended-release dipyridamole (ASA-ERDP) versus clopidogrel.

methodsIn this double-blind, 2-by-2 factorial trial, we randomly assigned patients to receive 25 mg of aspirin plus 200 mg of extended-release dipyridamole twice daily or to receive 75 mg of clopidogrel daily. The primary outcome was first recurrence of stroke. The secondary outcome was a composite of stroke, myocardial infarction, or death from vascular causes. Sequential statistical testing of noninferiority (margin of 1.075), followed by superiority testing, was planned.

resultsA total of 20,332 patients were followed for a mean of 2.5 years. Recurrent stroke occurred in 916 patients (9.0%) receiving ASA-ERDP and in 898 patients (8.8%) receiving clopidogrel (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11). The secondary outcome occurred in 1333 patients (13.1%) in each group (hazard ratio for ASA-ERDP, 0.99; 95% CI, 0.92 to 1.07). There were more major hemorrhagic events among ASA-ERDP recipients (419 [4.1%]) than among clopidogrel recipients (365 [3.6%]) (hazard ratio, 1.15; 95% CI, 1.00 to 1.32), including intracranial hemorrhage (hazard ratio, 1.42; 95% CI, 1.11 to 1.83). The net risk of recurrent stroke or major hemorrhagic event was similar in the two groups (1194 ASA-ERDP recipients [11.7%], vs. 1156 clopidogrel recipients [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11).

conclusionsThe trial did not meet the predefined criteria for noninferiority but showed similar rates of recurrent stroke with ASA-ERDP and with clopidogrel. There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke. (ClinicalTrials.gov number, NCT00153062.)

Indexed as

AgedAngiotensin-Converting Enzyme InhibitorsAspirinBenzimidazolesBenzoatesBrain IschemiaClopidogrelDelayed-Action PreparationsDipyridamoleDouble-Blind MethodDrug Therapy, CombinationFactor Analysis, StatisticalFemaleHemorrhageHumansKaplan-Meier EstimateAngiotensin-Converting Enzyme InhibitorsAspirinBenzimidazolesBenzoatesClopidogrelDelayed-Action PreparationsDipyridamolePlatelet Aggregation InhibitorsTelmisartanTiclopidine

Identifiers

PMID18753638
PMCPMC2714259
OpenAlexW2397867274

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.