Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept

Stable Coronary Artery Disease Clinical Trial

— ISAR-PLASTER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312855
• Other study ID #: Revacept/CAD/02
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2017
• Est. completion date: March 26, 2020

Study information

• Verified date: April 2020
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: March 26, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Coronary Artery Disease

Intervention

Drug:
• Revacept 80 mg
single dose, intravenous application of 80 mg Revacept
• Revacept 160 mg
single dose, intravenous application of 180 mg Revacept
• Placebo
single dose, intravenous application of Placebo solution

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Campus Virchow	Berlin
Germany	Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie	Frankfurt am Main
Germany	Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I	Mainz
Germany	Deutsches Herzzentrum München	Munich	Bavaria
Germany	Klinikum der Universität München, Medizinische Klinik und Poliklinik I	Munich
Germany	Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik	Munich
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (5)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	AdvanceCor GmbH, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), German Federal Ministry of Education and Research, Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint-composite endpoint of death and myocardial injury	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	All cause mortality	All cause mortality	within 30 days after randomisation
Secondary	Myocardial infarction	Myocardial infarction	within 30 days after randomisation
Secondary	PCI-related (type 4) myocardial infarction	PCI-related (type 4) myocardial infarction	within 30 days after randomisation
Secondary	Definite stent thrombosis	Definite stent thrombosis	within 30 days after randomisation
Secondary	Urgent coronary revascularization	Urgent coronary revascularization	within 30 days after randomisation
Secondary	Stroke	Stroke	within 30 days after randomisation
Secondary	Peak potprocedural high-sensitivity troponin T level	Peak potprocedural high-sensitivity troponin T level	within 48 hours after randomisation
Secondary	Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)	Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)	within 30 days after randomisation