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

NCT03312855 | Completed Phase 2 DMC

• 1 other identifier: Revacept/CAD/02
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Stable Coronary Artery Disease

Keywords

coronary artery disease; platelet inhibition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• All cause mortality

  within 30 days after randomisation

• Myocardial infarction

  within 30 days after randomisation

• PCI-related (type 4) myocardial infarction

  within 30 days after randomisation

• Definite stent thrombosis

  within 30 days after randomisation

• Urgent coronary revascularization

  within 30 days after randomisation

Study Arms (3)

Revacept 80 mg

EXPERIMENTAL

single dose, intravenous

Drug: Revacept 80 mg

Revacept 160 mg

EXPERIMENTAL

single dose, intravenous

Drug: Revacept 160 mg

Placebo

PLACEBO COMPARATOR

single dose, intravenous

Drug: Placebo

Interventions

Revacept 80 mg DRUG

single dose, intravenous application of 80 mg Revacept

Revacept 80 mg

Revacept 160 mg DRUG

single dose, intravenous application of 180 mg Revacept

Revacept 160 mg

Placebo DRUG

single dose, intravenous application of Placebo solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• AdvanceCor GmbH: collaborator
• Technical University of Munich: collaborator
• German Federal Ministry of Education and Research: collaborator

Study Sites (8)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Charité - Universitätsmedizin Berlin, Campus Virchow

Berlin, 13353, Germany

Location

Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie

Frankfurt am Main, 60590, Germany

Location

Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I

Mainz, 55131, Germany

Location

Klinikum der Universität München, Medizinische Klinik und Poliklinik I

Munich, 81377, Germany

Location

Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik

Munich, 81675, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Mayer K, Hein-Rothweiler R, Schupke S, Janisch M, Bernlochner I, Ndrepepa G, Sibbing D, Gori T, Borst O, Holdenrieder S, Kupka D, Petzold T, Bradaric C, Okrojek R, Leistner DM, Trippel TD, Munzel T, Landmesser U, Pieske B, Zeiher AM, Gawaz MP, Hapfelmeier A, Laugwitz KL, Schunkert H, Kastrati A, Massberg S. Efficacy and Safety of Revacept, a Novel Lesion-Directed Competitive Antagonist to Platelet Glycoprotein VI, in Patients Undergoing Elective Percutaneous Coronary Intervention for Stable Ischemic Heart Disease: The Randomized, Double-blind, Placebo-Controlled ISAR-PLASTER Phase 2 Trial. JAMA Cardiol. 2021 Jul 1;6(7):753-761. doi: 10.1001/jamacardio.2021.0475.

  PMID: 33787834 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Revacept

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Adnan Kastrati, MD

  Deutsches Herzzentrum München

  STUDY CHAIR

• Steffen Massberg, MD

  Klinikum der Universität München

  STUDY CHAIR

• Stefanie Schuepke, MD

  Deutsches Herzzentrum Muenchen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: with 2 doses (80 and 160 mg) of Revacept versus placebo

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: November 20, 2017
• Primary Completion: February 29, 2020
• Study Completion: March 26, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)