Evidence map›Paper›PMID 21146637›Full record

Trial reportContemporary clinical trials2011

Rationale and design of a phase II clinical trial of aspirin and simvastatin for the treatment of pulmonary arterial hypertension: ASA-STAT.

Steven M Kawut, Emilia Bagiella, Daichi Shimbo, David J Lederer, Nadine Al-Naamani, Kari E Roberts, R Graham Barr, Wendy Post, Evelyn M Horn, Russell Tracy and 3 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.2field-weighted citation impact, top 34% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Steven M KawutPenn Cardiovascular Institute, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, United States. kawut@upenn.edu
Emilia Bagiella
Daichi Shimbo
David J Lederer
Nadine Al-Naamani
Kari E Roberts
R Graham Barr
Wendy Post
Evelyn M Horn
Russell Tracy
Paul Hassoun
Reda Girgis
ASA-STAT Study Group
Columbia University · USJohns Hopkins Medicine · USCornell University · USJohns Hopkins University · USTufts University · USUniversity of Pennsylvania · USUniversity of Vermont · 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
TUFTS CLINICAL AND TRANSLATION SCIENCE INSTITUTE (UL1): BPCAUL1RR025752 · NCRR · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2008 to 2011
$17.6M
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 UL1RR024134NCRR NIH HHS UL1 RR024156NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1 RR025752NHLBI NIH HHS HL082895-S1NHLBI NIH HHS R01 HL082895
6 · The paper itself

Abstract

backgroundPulmonary arterial hypertension (PAH) is a progressive disease which causes exercise limitation, heart failure, and death. Aspirin and simvastatin are highly effective and safe therapies for other cardiovascular diseases characterized by platelet activation and endothelial dysfunction, but have not been formally studied in PAH.

methodsASA-STAT is a phase II, randomized, double-blind, placebo-controlled 2 × 2 factorial clinical trial of aspirin and simvastatin in patients with PAH. A total of 92 subjects were to be randomized to aspirin or aspirin placebo and simvastatin or simvastatin placebo. The primary outcome is the distance walked in 6 min at 6 months after randomization. Secondary measures include brachial artery flow-mediated dilation, circulating biomarkers of platelet and endothelial function, functional class, quality-of-life, and time to clinical end points. The incidence of adverse events will be compared between treatment groups. SCREENING AND ENROLLMENT: We screened a total of 712 individuals with PAH. Sixty-five subjects were enrolled when the trial was terminated for futility in reaching the primary end point for simvastatin.

conclusionsThis study aims to determine whether aspirin or simvastatin have beneficial biologic or clinical effects in patients with PAH. The safety and side effects of these commonly prescribed cardiovascular drugs will also be assessed.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalAspirinBiomarkersC-Reactive ProteinData Interpretation, StatisticalDouble-Blind MethodFamilial Primary Pulmonary HypertensionHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypertension, PulmonaryP-SelectinQuality of LifeRandomized Controlled Trials as TopicSimvastatinTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalAspirinBiomarkersC-Reactive ProteinHydroxymethylglutaryl-CoA Reductase InhibitorsP-SelectinSimvastatin

Identifiers

PMID21146637
PMCPMC3034822
OpenAlexW2163437068

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.