Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept (ISAR-PLASTER)

April 17, 2020 updated by: Deutsches Herzzentrum Muenchen

Revacept, a Novel Inhibitor of Platelet Adhesion in Patients With Stable Coronary Artery Disease Undergoing Elective Percutaneous Coronary Interventions: a Phase II, Multicentre, Randomised, Double-blind and Placebo-controlled Study

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revacept 80 mg
single dose, intravenous
single dose, intravenous application of 80 mg Revacept
Experimental: Revacept 160 mg
single dose, intravenous
single dose, intravenous application of 180 mg Revacept
Placebo Comparator: Placebo
single dose, intravenous
single dose, intravenous application of Placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint-composite endpoint of death and myocardial injury
Time Frame: within 48 hours from randomisation
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).
within 48 hours from randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: within 30 days after randomisation
All cause mortality
within 30 days after randomisation
Myocardial infarction
Time Frame: within 30 days after randomisation
Myocardial infarction
within 30 days after randomisation
PCI-related (type 4) myocardial infarction
Time Frame: within 30 days after randomisation
PCI-related (type 4) myocardial infarction
within 30 days after randomisation
Definite stent thrombosis
Time Frame: within 30 days after randomisation
Definite stent thrombosis
within 30 days after randomisation
Urgent coronary revascularization
Time Frame: within 30 days after randomisation
Urgent coronary revascularization
within 30 days after randomisation
Stroke
Time Frame: within 30 days after randomisation
Stroke
within 30 days after randomisation
Peak potprocedural high-sensitivity troponin T level
Time Frame: within 48 hours after randomisation
Peak potprocedural high-sensitivity troponin T level
within 48 hours after randomisation
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
Time Frame: within 30 days after randomisation
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
within 30 days after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Steffen Massberg, MD, Klinikum der Universität München
  • Study Director: Stefanie Schuepke, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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