Evidence map›Paper›PMID 21593252›Full record

Trial reportCirculation2011

Randomized clinical trial of aspirin and simvastatin for pulmonary arterial hypertension: ASA-STAT.

Steven M Kawut, Emilia Bagiella, David J Lederer, Daichi Shimbo, Evelyn M Horn, Kari E Roberts, Nicholas S Hill, R Graham Barr, Erika B Rosenzweig, Wendy Post and 5 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00384865. Cited by 50 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 4 pooled it
13.0field-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.

NCT00384865 phase2terminated

A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

Ran2006Enrolled64Registered outcomes3Posted comparisons0ConditionsHypertension, PulmonaryArmsAspirin, Placebo, simvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 4 syntheses or guidelines pooled it, 141 citations in OpenAlex.

  1. Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
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  8. Article
  9. Review
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  11. Article
  12. Article
  13. Article
  14. Cholesterol: A Novel Regulator of Vasoreactivity in Pulmonary Arteries.American journal of respiratory cell and molecular biology · 2020
    Article
  15. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

Steven M KawutPenn Cardiovascular Institute, Department of Medicine and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 423 Guardian Drive, Philadelphia, PA 19104, USA. kawut@upenn.edu
Emilia Bagiella
David J Lederer
Daichi Shimbo
Evelyn M Horn
Kari E Roberts
Nicholas S Hill
R Graham Barr
Erika B Rosenzweig
Wendy Post
Russell P Tracy
Harold I Palevsky
Paul M Hassoun
Reda E Girgis
ASA-STAT Study Group
Tufts Medical Center · USUniversity of Pennsylvania · USJohns Hopkins Medicine · USJohns Hopkins University · USCornell University · US

Funding

Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
SCLERODERMA-ASSOCIATED PAHP50HL084946 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI HASSOUN, PAUL M. · 2007 to 2011
$20.6M
TUFTS CLINICAL AND TRANSLATION SCIENCE INSTITUTE (UL1): BPCAUL1RR025752 · NCRR · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2008 to 2011
$17.6M
The Role of Xanthine Oxidoreductase in Ventilator-Associated Lung InjuryR01HL049441 · NHLBI · TUFTS MEDICAL CENTER · PI HASSOUN, PAUL M. · 1999 to 2013
$3.7M
Aspirin and Simvastatin--Pulmonary Arterial HypertensionR01HL082895 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI KAWUT, STEVEN M · 2006 to 2009
$2.4M
NCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1 RR024156NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1 RR025752NHLBI NIH HHS HL082895-S1NHLBI NIH HHS P50 HL084946NHLBI NIH HHS R01 HL049441NHLBI NIH HHS R01 HL082895
6 · The paper itself

Abstract

backgroundPulmonary arterial hypertension (PAH) is a progressive disease that causes exercise limitation, heart failure, and death. We aimed to determine the safety and efficacy of aspirin and simvastatin in PAH. METHODS AND

resultsWe performed a randomized, double-blind, placebo-controlled 2×2 factorial clinical trial of aspirin and simvastatin in patients with PAH receiving background therapy at 4 centers. A total of 92 patients with PAH were to be randomized to aspirin 81 mg or matching placebo and simvastatin 40 mg or matching placebo. The primary outcome was 6-minute walk distance at 6 months. Sixty-five subjects had been randomized when the trial was terminated by the Data Safety and Monitoring Board after an interim analysis showed futility in reaching the primary end point for simvastatin. After adjustment for baseline 6-minute walk distance, there was no significant difference in the 6-minute walk distance at 6 months between aspirin (n=32) and placebo (n=33; placebo-corrected difference −0.5 m, 95% confidence interval −28.4 to 27.4 m; P=0.97) or between simvastatin (n=32) and placebo (n=33; placebo-corrected difference −27.6 m, 95% confidence interval −59.6 to 4.3 m; P=0.09). There tended to be more major bleeding episodes with aspirin than with placebo (4 events versus 1 event, respectively; P=0.17).

conclusionsNeither aspirin nor simvastatin had a significant effect on the 6-minute walk distance, although patients randomized to simvastatin tended to have a lower 6-minute walk distance at 6 months. These results do not support the routine treatment of patients with PAH with these medications.

Indexed as

AdultAspirinCholesterolDouble-Blind MethodDrug Therapy, CombinationEndothelium, VascularExercise ToleranceFemaleHumansHypertension, PulmonaryMaleMiddle AgedRetrospective StudiesSimvastatinTreatment OutcomeWalkingAspirinCholesterolSimvastatin

Identifiers

PMID21593252
PMCPMC3427737
OpenAlexW1969722648

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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.