Evidence map›Paper›PMID 33638931›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2021

Effects of simvastatin on tissue factor pathway of blood coagulation in STATCOPE (Simvastatin in the prevention of COPD exacerbations) trial.

A Koneti Rao, Fabiola Del Carpio-Cano, Sumalaxmi Janapati, Huaqing Zhao, Helen Voelker, Xiaoning Lu, Gerard Criner, NIH COPD Clinical Research Network, the Canadian Institute of Health Research Investigators

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Statins-From Fungi to Pharmacy.International journal of molecular sciences · 2023
    Review
  2. Article
  3. Article
  4. Statins and Hemostasis: Therapeutic Potential Based on Clinical Evidence.Advances in experimental medicine and biology · 2023
    Review
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

8 authors at 2 institutions in 1 country.

A Koneti RaoSol Sherry Thrombosis Research Center, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.ORCID 0000-0002-3078-7778
Fabiola Del Carpio-CanoSol Sherry Thrombosis Research Center, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Sumalaxmi JanapatiSol Sherry Thrombosis Research Center, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Huaqing ZhaoDepartment of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Helen VoelkerDepartment of Biostatistics, University of Minnesota, Minneapolis, MN, USA.
Xiaoning LuDepartment of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Gerard CrinerDepartment of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
NIH COPD Clinical Research Network, the Canadian Institute of Health Research Investigators
Temple University · USUniversity of Minnesota · US

Funding

COPD Clinical Research Network - Data Coordinating CenterU10HL074424 · NHLBI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI CONNETT, JOHN E · 2003 to 2011
$21.0M
Novel Strategies Targeting Acute Exacerbation of COPDU10HL074409 · NHLBI · DENVER HEALTH AND HOSPITAL AUTHORITY · PI ALBERT, RICHARD K · 2003 to 2007
$4.1M
COPD Exacerbations: Pharmacogenetic Approaches to TherapyU10HL074428 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI WASHKO, GEORGE R · 2003 to 2007
$3.4M
UAB/BVAMC Clinical Center in COPDU10HL074418 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI DRANSFIELD, MARK T · 2003 to 2007
$3.3M
Strategies to Improve COPD ManagementU10HL074407 · NHLBI · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI CASABURI, RICHARD · 2003 to 2007
$3.2M
COPD Clinical Research Network & Clinical Research Skills Core DevelopmentU10HL074408 · NHLBI · TEMPLE UNIV OF THE COMMONWEALTH · PI CRINER, GERARD J · 2004 to 2007
$2.7M
Drug therapy for preventing COPD exacerbationsU10HL074416 · NHLBI · MINNESOTA VETERANS RESEARCH INST · PI NIEWOEHNER, DENNIS E. · 2003 to 2007
$2.7M
Clinical Center-COPD Clinical Research NetworkU10HL074441 · NHLBI · UNIVERSITY OF MARYLAND BALTIMORE · PI SCHARF, STEVEN M · 2003 to 2006
$2.6M
COPD Clinical Research NetworkU10HL074431 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LAZARUS, STEPHEN C · 2003 to 2006
$2.2M
Strategies to Prevent COPD ExacerbationU10HL074422 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MARTINEZ, FERNANDO J · 2004 to 2007
$2.0M
COPD Clinical Research NetworkU10HL074439 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SCIURBA, FRANK · 2004 to 2007
$1.7M
CIHR 115074NHLBI NIH HHS U10 HL074407NHLBI NIH HHS U10 HL074408NHLBI NIH HHS U10 HL074409NHLBI NIH HHS U10 HL074416NHLBI NIH HHS U10 HL074418NHLBI NIH HHS U10 HL074422NHLBI NIH HHS U10 HL074424NHLBI NIH HHS U10 HL074428NHLBI NIH HHS U10 HL074431NHLBI NIH HHS U10 HL074439NHLBI NIH HHS U10 HL074441
6 · The paper itself

Abstract

backgroundStatins are widely used to lower lipids and reduce cardiovascular events. In vitro studies and small studies in patients with hyperlipidemias show statins inhibit tissue factor (TF) and blood coagulation mechanisms. We assessed the effects of simvastatin on TF and coagulation biomarkers in patients entered in STATCOPE, a multicenter, randomized, placebo-controlled trial of simvastatin (40 mg daily) versus placebo on exacerbation rates in patients with chronic obstructive pulmonary disease (COPD).

methodsIn 227 patients (114 simvastatin, 113 placebo; mean [± standard error of the mean] age 62 ± 0.53 years, 44.5% women) we measured (baseline, and 6 and 12 months): whole blood membrane TF-procoagulant activity (TF-PCA) and plasma factors VIIa, VII, VIII, fibrinogen, TF antigen, tissue factor pathway inhibitor (TFPI), thrombin-antithrombin complexes (TAT), and D-dimer. We excluded patients with diabetes, cardiovascular disease, and those taking or requiring a statin.

resultsIn the statin group, there was a small increase in TF-PCA (from 25.18 ± 1.08 to 30.36 ± 1.10 U/ml; p = .03) over 12 months; factors VIIa and VIII, fibrinogen, TAT, and D-dimer did not change. Plasma TFPI (from 52.4 ± 1.75 to 44.7 ± 1.78 ng/ml; p < .0001) and FVIIC (1.23 ± 0.04 to 1.15 ± 0.03 U/ml; p = .03) decreased and correlated with total cholesterol levels. No changes in biomarkers were observed with placebo.

conclusionsIn contrast to previous studies on statins, in COPD patients without diabetes, cardiovascular disease, or requiring a statin treatment, simvastatin (40 mg per day) did not decrease TF or factors VIIa and VIII, fibrinogen, TAT, or D-dimer. The decreases in TFPI and factor VII reflect the decrease in serum lipids.

Indexed as

Pulmonary Disease, Chronic ObstructiveThromboplastinBlood CoagulationFactor VIIaFemaleHumansMaleMiddle AgedSimvastatinFactor VIIaSimvastatinThromboplastinblood coagulationchronic obstructive pulmonary diseasesimvastatinstatintissue factor pathway

Identifiers

PMID33638931
PMCPMC8238804
OpenAlexW3132494145

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.