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CompletedNCT03312855ISAR-PLASTERUpdated Apr 20, 2020

Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept

A Phase 2 interventional study of Revacept 80 mg and Revacept 160 mg in Stable Coronary Artery Disease, sponsored by Deutsches Herzzentrum Muenchen. Completed at 8 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by Deutsches Herzzentrum Muenchen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
334
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo in patients with stable coronary artery disease undergoing PCI.

Read the detailed description

Revacept is a protein that is made up of an Fc fragment ("fragment crystallisable") fused to the GPVI receptor (the endogenous platelet collagen receptor). Consequently, Revacept binds to its ligand (collagen) on atherosclerotic plaques preventing circulating thrombocytes from binding to collagen exposed by the injured plaque. All this is achieved without affecting systemic hemostasis.

Thus, blocking of GPVI-dependent pathways by interfering with vascular collagen sites is commonly seen as an attractive target for an anti-platelet therapy of atherosclerotic diseases.

02

Conditions studied

  • Stable Coronary Artery Disease

Keywords

  • coronary artery disease
  • platelet inhibition
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed written informed consent
  • Men and women >18 years of age
  • Diagnosis: Clinically stable coronary artery disease
  • Angiographic evidence of coronary artery disease
  • Indication for PCI

Exclusion criteria

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.
  • Women who are pregnant or breastfeeding or are planning pregnancy during course of trial
  • Women with a positive pregnancy test on enrolment or prior to investigational product administration.
  • Patients with elevated high sensitivity cardiac troponin T levels at screening
  • Patients receiving antithrombotic therapy with Prasugrel or Ticagrelor within 7 days prior to randomisation
  • History of hypersensitivity, contraindication or serious adverse reaction to any component of the study drug (GPVI-Fc, sucrose, mannitol), acetylsalicylic acid or clopidogrel
  • History of bleeding diathesis or active bleeding within the last 30 days
  • Recent intracerebral haemorrhage or trauma within the last 3 months
  • Thrombocytopenia (platelet count \<30000/mm3) at screening
  • Sustained hypertension (systolic BP >179mmHg or diastolic BP >109mmHg) at screening
  • Renal failure (estimated glomerular filtration rate \< 30ml/min and/or dialysis)
  • Severe systemic disease, such as known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
  • Unable to provide informed consent (e.g. severe dementia, or psychosis)
  • Current severe liver dysfunction (transaminase level >5-fold the upper normal range limit)
  • Patients with an indication for anticoagulant therapy
  • Participation in any other clinical interventional trial (drug/device) within less than 30 days prior to screening
  • Any other contraindication to perform PCI
  • Any planned additional PCI or surgery within 30 days after randomization
  • Suspected poor capability to follow instructions and cooperate
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
334 participants (actual)

Study arms

  • Experimental
    Revacept 80 mg

    single dose, intravenous

    Drug: Revacept 80 mg

  • Experimental
    Revacept 160 mg

    single dose, intravenous

    Drug: Revacept 160 mg

  • Placebo comparator
    Placebo

    single dose, intravenous

    Drug: Placebo

Interventions

  • DrugRevacept 80 mg

    single dose, intravenous application of 80 mg Revacept

  • DrugRevacept 160 mg

    single dose, intravenous application of 180 mg Revacept

  • DrugPlacebo

    single dose, intravenous application of Placebo solution

05

What researchers measure

Primary outcomes

  1. Primary endpoint-composite endpoint of death and myocardial injury

    A composite endpoint of death or myocardial injury (defined as increase in cardiac biomarker - high sensitivity cardiac troponin T of at least 5 times the upper limit of norm (ULN) within 48 hours from randomisation).

    Time frame: within 48 hours from randomisation

Secondary outcomes

  1. All cause mortality

    All cause mortality

    Time frame: within 30 days after randomisation

  2. Myocardial infarction

    Myocardial infarction

    Time frame: within 30 days after randomisation

  3. PCI-related (type 4) myocardial infarction

    PCI-related (type 4) myocardial infarction

    Time frame: within 30 days after randomisation

  4. Definite stent thrombosis

    Definite stent thrombosis

    Time frame: within 30 days after randomisation

  5. Urgent coronary revascularization

    Urgent coronary revascularization

    Time frame: within 30 days after randomisation

  6. Stroke

    Stroke

    Time frame: within 30 days after randomisation

  7. Peak potprocedural high-sensitivity troponin T level

    Peak potprocedural high-sensitivity troponin T level

    Time frame: within 48 hours after randomisation

  8. Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)

    Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)

    Time frame: within 30 days after randomisation

06

Study locations

8 sites
  • Deutsches Herzzentrum München
    Munich, Bavaria 80636, Germany
  • Universitätsmedizin Berlin, Campus Benjamin Franklin
    Berlin, 12203, Germany
  • Charité - Universitätsmedizin Berlin, Campus Virchow
    Berlin, 13353, Germany
  • Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie
    Frankfurt am Main, 60590, Germany
  • Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I
    Mainz, 55131, Germany
  • Klinikum der Universität München, Medizinische Klinik und Poliklinik I
    Munich, 81377, Germany
  • Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik
    Munich, 81675, Germany
  • Universitätsklinikum Tübingen
    Tübingen, 72076, Germany
07

References and documents

Publications

  • Mayer K, Hein-Rothweiler R, Schupke S, Janisch M, Bernlochner I, Ndrepepa G, Sibbing D, Gori T, Borst O, Holdenrieder S, Kupka D, Petzold T, Bradaric C, Okrojek R, Leistner DM, Trippel TD, Munzel T, Landmesser U, Pieske B, Zeiher AM, Gawaz MP, Hapfelmeier A, Laugwitz KL, Schunkert H, Kastrati A, Massberg S. Efficacy and Safety of Revacept, a Novel Lesion-Directed Competitive Antagonist to Platelet Glycoprotein VI, in Patients Undergoing Elective Percutaneous Coronary Intervention for Stable Ischemic Heart Disease: The Randomized, Double-blind, Placebo-Controlled ISAR-PLASTER Phase 2 Trial. JAMA Cardiol. 2021 Jul 1;6(7):753-761. doi: 10.1001/jamacardio.2021.0475. PubMed 33787834 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03312855
Lead sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), AdvanceCor GmbH, Technical University of Munich, German Federal Ministry of Education and Research
Responsible party
Sponsor
First posted
Oct 18, 2017
Start date
Nov 20, 2017
Primary completion
Feb 29, 2020
Completion
Mar 26, 2020
Last update
Apr 20, 2020

Study contacts

Adnan Kastrati, MD
study chair · Deutsches Herzzentrum München
Steffen Massberg, MD
study chair · Klinikum der Universität München
Stefanie Schuepke, MD
study director · Deutsches Herzzentrum Muenchen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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