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

Primary Purpose

Stable Coronary Artery Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Revacept 80 mg

Revacept 160 mg

Placebo

About this trial

This is an interventional treatment trial for Stable Coronary Artery Disease focused on measuring coronary artery disease, platelet inhibition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Deutsches Herzzentrum München
Universitätsmedizin Berlin, Campus Benjamin Franklin
Charité - Universitätsmedizin Berlin, Campus Virchow
Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie
Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I
Klinikum der Universität München, Medizinische Klinik und Poliklinik I
Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik
Universitätsklinikum Tübingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Revacept 80 mg

Revacept 160 mg

Placebo

Arm Description

single dose, intravenous

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

All cause mortality

Myocardial infarction

PCI-related (type 4) myocardial infarction

Definite stent thrombosis

Urgent coronary revascularization

Stroke

Peak potprocedural high-sensitivity troponin T level

Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)

Full Information

NCT ID

NCT03312855

First Posted

October 13, 2017

Last Updated

April 17, 2020

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), AdvanceCor GmbH, Technical University of Munich, German Federal Ministry of Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT03312855

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

November 20, 2017 (Actual)

Primary Completion Date

February 29, 2020 (Actual)

Study Completion Date

March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), AdvanceCor GmbH, Technical University of Munich, German Federal Ministry of Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Coronary Artery Disease

Keywords

coronary artery disease, platelet inhibition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

334 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Revacept 80 mg

Arm Type

Experimental

Arm Description

single dose, intravenous

Arm Title

Revacept 160 mg

Arm Type

Experimental

Arm Description

single dose, intravenous

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

single dose, intravenous

Intervention Type

Drug

Intervention Name(s)

Revacept 80 mg

Intervention Description

single dose, intravenous application of 80 mg Revacept

Intervention Type

Drug

Intervention Name(s)

Revacept 160 mg

Intervention Description

single dose, intravenous application of 180 mg Revacept

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

single dose, intravenous application of Placebo solution

Primary Outcome Measure Information:

Title

Primary endpoint-composite endpoint of death and myocardial injury

Description

Time Frame

within 48 hours from randomisation

Secondary Outcome Measure Information:

Title

All cause mortality

Description

All cause mortality

Time Frame

within 30 days after randomisation

Title

Myocardial infarction

Description

Myocardial infarction

Time Frame

within 30 days after randomisation

Title

PCI-related (type 4) myocardial infarction

Description

PCI-related (type 4) myocardial infarction

Time Frame

within 30 days after randomisation

Title

Definite stent thrombosis

Description

Definite stent thrombosis

Time Frame

within 30 days after randomisation

Title

Urgent coronary revascularization

Description

Urgent coronary revascularization

Time Frame

within 30 days after randomisation

Title

Stroke

Description

Stroke

Time Frame

within 30 days after randomisation

Title

Peak potprocedural high-sensitivity troponin T level

Description

Peak potprocedural high-sensitivity troponin T level

Time Frame

within 48 hours after randomisation

Title

Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)

Description

Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)

Time Frame

within 30 days after randomisation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adnan Kastrati, MD

Organizational Affiliation

Deutsches Herzzentrum München

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Steffen Massberg, MD

Organizational Affiliation

Klinikum der Universität München

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Stefanie Schuepke, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Study Director

Facility Information:

Facility Name

Deutsches Herzzentrum München

City

Munich

State/Province

Bavaria

ZIP/Postal Code

80636

Country

Germany

Facility Name

Universitätsmedizin Berlin, Campus Benjamin Franklin

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Charité - Universitätsmedizin Berlin, Campus Virchow

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Klinikum der Universität München, Medizinische Klinik und Poliklinik I

City

Munich

ZIP/Postal Code

81377

Country

Germany

Facility Name

Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33787834

Citation

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.

Results Reference

derived

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

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