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

• Status: Completed
• Trial end date: 2020-03-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: AdvanceCor GmbH; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK); German Federal Ministry of Education and Research; Technische Universität München
• Treatments: Immunoglobulin Fc Fragments

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)