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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
334

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • 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 München

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Revacept 80 mg
single dose, intravenous
Drug: Revacept 80 mg
single dose, intravenous application of 80 mg Revacept
Experimental: Revacept 160 mg
single dose, intravenous
Drug: Revacept 160 mg
single dose, intravenous application of 180 mg Revacept
Placebo Comparator: Placebo
single dose, intravenous
Drug: Placebo
single dose, intravenous application of Placebo solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deutsches Herzzentrum Muenchen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research
Technical University of Munich
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
AdvanceCor GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Revacept/CAD/02

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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Conditions

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Locations

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