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

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ClinicalTrials.gov Identifier: NCT03312855
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
AdvanceCor GmbH
Technische Universität München
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief 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.

Condition or disease Intervention/treatment Phase
Stable Coronary Artery Disease Drug: Revacept 80 mg Drug: Revacept 160 mg Drug: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: with 2 doses (80 and 160 mg) of Revacept versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: within 30 days after randomisation ]
    All cause mortality

  2. Myocardial infarction [ Time Frame: within 30 days after randomisation ]
    Myocardial infarction

  3. PCI-related (type 4) myocardial infarction [ Time Frame: within 30 days after randomisation ]
    PCI-related (type 4) myocardial infarction

  4. Definite stent thrombosis [ Time Frame: within 30 days after randomisation ]
    Definite stent thrombosis

  5. Urgent coronary revascularization [ Time Frame: within 30 days after randomisation ]
    Urgent coronary revascularization

  6. Stroke [ Time Frame: within 30 days after randomisation ]
    Stroke

  7. Peak potprocedural high-sensitivity troponin T level [ Time Frame: within 48 hours after randomisation ]
    Peak potprocedural high-sensitivity troponin T level

  8. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312855


Contacts
Contact: Adnan Kastrati, MD +49891218 ext 4578 kastrati@dhm.mhn.de
Contact: Marion Janisch, MD +49891218 ext 1547 janischm@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum München Recruiting
Munich, Bavaria, Germany, 80636
Contact: Adnan Kastrati, MD         
Contact: Janisch Marion, MD         
Principal Investigator: Adnan Kastrati, MD         
Sub-Investigator: Katharina Mayer, MD         
Charité - Universitätsmedizin Berlin, Campus Virchow Not yet recruiting
Berlin, Germany, 13353
Contact: Tobias T, MD         
Contact: Frank Edelmann, MD         
Principal Investigator: Tobias Trippel, MD         
Sub-Investigator: Frank Edelmann, MD         
Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie Recruiting
Frankfurt am Main, Germany, 60590
Contact: Mariuca Vasa-Nicotera, MD         
Contact: Andreas Zeiher, MD         
Principal Investigator: Mariuca Vasa-Nicotera, MD         
Sub-Investigator: Andreas Zeiher, MD         
Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I Recruiting
Mainz, Germany, 55131
Contact: Tommaso Gori, MD         
Contact: Thomas Münzel, MD         
Principal Investigator: Tommaso Gori, MD         
Sub-Investigator: Thomas Münzel, MD         
Klinikum der Universität München, Medizinische Klinik und Poliklinik I Recruiting
Munich, Germany, 81377
Contact: Dirk Sibbing, MD         
Contact: Gross Lisa, MD         
Principal Investigator: Dirk Sibbing, MD         
Sub-Investigator: Lisa Gross, MD         
Sub-Investigator: Danny Kupka, MD         
Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik Recruiting
Munich, Germany, 81675
Contact: Karl-Ludwig Laugwitz, MD         
Contact: Rainer Okrojek, MD         
Principal Investigator: Karl-Ludwig Laugwitz, MD         
Sub-Investigator: Rainer Okrojek, MD         
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II Not yet recruiting
Regensburg, Germany, 93053
Contact: Marcus Fischer, MD         
Contact: Andrea Bässler, MD         
Principal Investigator: Marcus Fischer, MD         
Sub-Investigator: Andrea Bässler, MD         
Universitätsklinikum Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Oliver Borst, MD         
Contact: Geisler Tobias, MD         
Principal Investigator: Oliver Borst, MD         
Sub-Investigator: Geisler Tobias, MD         
Sub-Investigator: Rath Dominik, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
AdvanceCor GmbH
Technische Universität München
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum München
Study Chair: Steffen Massberg, MD Klinikum der Universität München
Study Director: Stefanie Schuepke, MD Deutsches Herzzentrum Muenchen

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT03312855     History of Changes
Other Study ID Numbers: Revacept/CAD/02
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deutsches Herzzentrum Muenchen:
coronary artery disease
platelet inhibition

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases