Title

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

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    revacept ...
  • Study Participants

    334
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.
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 Started
Nov 20
2017
Primary Completion
Feb 29
2020
Study Completion
Mar 26
2020
Last Update
Apr 20
2020

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

Revacept 160 mg Experimental

single dose, intravenous

Placebo Placebo Comparator

single dose, intravenous

Revacept 80 mg Experimental

single dose, intravenous

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)
No Results Posted