Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312855
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : April 20, 2020
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
AdvanceCor GmbH
Technische Universität München
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE October 18, 2017
Last Update Posted Date April 20, 2020
Actual Study Start Date  ICMJE November 20, 2017
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
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 of at least 5 times the upper limit of norm (ULN) within 48 hours from randomisation).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • All cause mortality [ Time Frame: within 30 days after randomisation ]
    All cause mortality
  • Myocardial infarction [ Time Frame: within 30 days after randomisation ]
    Myocardial infarction
  • PCI-related (type 4) myocardial infarction [ Time Frame: within 30 days after randomisation ]
    PCI-related (type 4) myocardial infarction
  • Definite stent thrombosis [ Time Frame: within 30 days after randomisation ]
    Definite stent thrombosis
  • Urgent coronary revascularization [ Time Frame: within 30 days after randomisation ]
    Urgent coronary revascularization
  • Stroke [ Time Frame: within 30 days after randomisation ]
    Stroke
  • Peak potprocedural high-sensitivity troponin T level [ Time Frame: within 48 hours after randomisation ]
    Peak potprocedural high-sensitivity troponin T level
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • All cause mortality [ Time Frame: within 30 days after randomisation ]
    All cause mortality
  • Myocardial infarction [ Time Frame: within 30 days after randomisation ]
    Myocardial infarction
  • PCI-related (type 4) myocardial infarction [ Time Frame: within 30 days after randomisation ]
    PCI-related (type 4) myocardial infarction
  • Definite stent thrombosis [ Time Frame: within 30 days after randomisation ]
    Definite stent thrombosis
  • Urgent coronary revascularization [ Time Frame: within 30 days after randomisation ]
    Urgent coronary revascularization
  • Stroke [ Time Frame: within 30 days after randomisation ]
    Stroke
  • Peak potprocedural high-sensitivity troponin level [ Time Frame: within 30 days after randomisation ]
    Peak potprocedural high-sensitivity troponin level
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Stable Coronary Artery Disease
Intervention  ICMJE
  • Drug: Revacept 80 mg
    single dose, intravenous application of 80 mg Revacept
  • Drug: Revacept 160 mg
    single dose, intravenous application of 180 mg Revacept
  • Drug: Placebo
    single dose, intravenous application of Placebo solution
Study Arms  ICMJE
  • Experimental: Revacept 80 mg
    single dose, intravenous
    Intervention: Drug: Revacept 80 mg
  • Experimental: Revacept 160 mg
    single dose, intravenous
    Intervention: Drug: Revacept 160 mg
  • Placebo Comparator: Placebo
    single dose, intravenous
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2020)
334
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
332
Actual Study Completion Date  ICMJE March 26, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03312855
Other Study ID Numbers  ICMJE Revacept/CAD/02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deutsches Herzzentrum Muenchen
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • AdvanceCor GmbH
  • Technische Universität München
  • German Federal Ministry of Education and Research
Investigators  ICMJE
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
PRS Account Deutsches Herzzentrum Muenchen
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP