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

German Heart Center Munich

Status and phase: Completed; Phase 2

Conditions: Stable Coronary Artery Disease

Treatments: Drug: Revacept 80 mg; Drug: Revacept 160 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03312855

Revacept/CAD/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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334 participants in 3 patient groups, including a placebo group

Revacept 80 mg

Experimental group

Description:

single dose, intravenous

Treatment:

Drug: Revacept 80 mg

Revacept 160 mg

Experimental group

Description:

single dose, intravenous

Treatment:

Drug: Revacept 160 mg

Placebo

Placebo Comparator group

Description:

single dose, intravenous

Treatment:

Drug: Placebo