- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312855
Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept (ISAR-PLASTER)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
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
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Munich, Germany, 81377
- Klinikum der Universität München, Medizinische Klinik und Poliklinik I
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Munich, Germany, 81675
- Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik
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Tübingen, Germany, 72076
- Universitatsklinikum Tubingen
-
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Bavaria
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Munich, Bavaria, Germany, 80636
- Deutsches Herzzentrum Munchen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Study Chair: Steffen Massberg, MD, Klinikum der Universität München
- Study Director: Stefanie Schuepke, MD, Deutsches Herzzentrum Muenchen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Revacept/CAD/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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