Evidence map›Paper›PMID 22859796›Full record

Trial reportEuropean heart journal2013

A Phase 2, randomized, partially blinded, active-controlled study assessing the efficacy and safety of variable anticoagulation reversal using the REG1 system in patients with acute coronary syndromes: results of the RADAR trial.

Thomas J Povsic, John P Vavalle, Laura H Aberle, Jaroslaw D Kasprzak, Mauricio G Cohen, Roxana Mehran, Christoph Bode, Christopher E Buller, Gilles Montalescot, Jan H Cornel and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
4.6field-weighted citation impact, top 4% 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

48 citing papers in PubMed, 105 citations in OpenAlex.

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  16. Factor IX(a) inhibitors: an updated patent review (2003-present).Expert opinion on therapeutic patents · 2022
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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

19 authors at 14 institutions in 6 countries.

Thomas J PovsicDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
John P Vavalle
Laura H Aberle
Jaroslaw D Kasprzak
Mauricio G Cohen
Roxana Mehran
Christoph Bode
Christopher E Buller
Gilles Montalescot
Jan H Cornel
Andrzej Rynkiewicz
Michael E Ring
Uwe Zeymer
Madhu Natarajan
Nicolas Delarche
Steven L Zelenkofske
Richard C Becker
John H Alexander
RADAR Investigators
Clinical Research Institute · USDuke Medical Center · USAssociation François Aupetit · FRGdańsk Medical University · PLHamilton General Hospital · CAHamilton Health Sciences · CAIcahn School of Medicine at Mount Sinai · USMedical University of Lodz · PLMedisch Centrum Alkmaar · NLProvidence Sacred Heart Medical Center · USRegen BioPharma (United States) · USSorbonne Université · FRTU Bergakademie Freiberg · DEUniversity of Miami · US

Funding

Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2003 to 2023
$6.7M
NHLBI NIH HHS L30 HL105128NHLBI NIH HHS T32 HL069749
6 · The paper itself

Abstract

aimsWe sought to determine the degree of anticoagulation reversal required to mitigate bleeding, and assess the feasibility of using pegnivacogin to prevent ischaemic events in acute coronary syndrome (ACS) patients managed with an early invasive approach. REG1 consists of pegnivacogin, an RNA aptamer selective factor IXa inhibitor, and its complementary controlling agent, anivamersen. REG1 has not been studied in invasively managed patients with ACS nor has an optimal level of reversal allowing safe sheath removal been defined. METHODS AND

resultsNon-ST-elevation ACS patients (n = 640) with planned early cardiac catheterization via femoral access were randomized 2:1:1:2:2 to pegnivacogin with 25, 50, 75, or 100% anivamersen reversal or heparin. The primary endpoint was total ACUITY bleeding through 30 days. Secondary endpoints included major bleeding and the composite of death, myocardial infarction, urgent target vessel revascularization, or recurrent ischaemia. Enrolment in the 25% reversal arm was suspended after 41 patients. Enrolment was stopped after three patients experienced allergic-like reactions. Bleeding occurred in 65, 34, 35, 30, and 31% of REG1 patients with 25, 50, 75, and 100% reversal and heparin. Major bleeding occurred in 20, 11, 8, 7, and 10% of patients. Ischaemic events occurred in 3.0 and 5.7% of REG1 and heparin patients, respectively.

conclusionAt least 50% reversal is required to allow safe sheath removal after cardiac catheterization. REG1 appears a safe strategy to anticoagulate ACS patients managed invasively and warrants further investigation in adequately powered clinical trials of patients who require short-term high-intensity anticoagulation.

Indexed as

Acute Coronary SyndromeAnticoagulantsAptamers, NucleotideCardiac CatheterizationCoagulantsFactor IXaFeasibility StudiesFemaleHemorrhageHeparinHumansMaleMiddle AgedMyocardial InfarctionMyocardial RevascularizationOligonucleotidesAnticoagulantsAptamers, NucleotideCoagulantsFactor IXaHeparinOligonucleotidesRB 006RB 007Acute coronary syndromesAnticoagulation reversalREG1

Identifiers

PMID22859796
PMCPMC3895957
OpenAlexW2155363644

What OpenQuestion holds

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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.