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

Sponsor

Deutsches Herzzentrum Muenchen (Other)

Overall Status

Completed

CT.gov ID

NCT03312855

Collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other), AdvanceCor GmbH (Industry), Technische Universität München (Other), German Federal Ministry of Education and Research (Other)

334

Enrollment

Locations

Arms

28.2

Actual Duration (Months)

41.8

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Coronary Artery Disease	Drug: Revacept 80 mg Drug: Revacept 160 mg Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

334 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 20, 2017

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

Mar 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Revacept 80 mg single dose, intravenous	Drug: Revacept 80 mg single dose, intravenous application of 80 mg Revacept
Experimental: Revacept 160 mg single dose, intravenous	Drug: Revacept 160 mg single dose, intravenous application of 180 mg Revacept
Placebo Comparator: Placebo single dose, intravenous	Drug: Placebo single dose, intravenous application of Placebo solution

Arm

Intervention/Treatment

Experimental: Revacept 80 mg

single dose, intravenous

Drug: Revacept 80 mg

single dose, intravenous application of 80 mg Revacept

Experimental: Revacept 160 mg

single dose, intravenous

Drug: Revacept 160 mg

single dose, intravenous application of 180 mg Revacept

Placebo Comparator: Placebo

single dose, intravenous

Drug: Placebo

single dose, intravenous application of Placebo solution

Outcome Measures

Primary Outcome Measures

Primary endpoint-composite endpoint of death and myocardial injury [within 48 hours from randomisation]
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 [within 30 days after randomisation]
All cause mortality
Myocardial infarction [within 30 days after randomisation]
Myocardial infarction
PCI-related (type 4) myocardial infarction [within 30 days after randomisation]
PCI-related (type 4) myocardial infarction
Definite stent thrombosis [within 30 days after randomisation]
Definite stent thrombosis
Urgent coronary revascularization [within 30 days after randomisation]
Urgent coronary revascularization
Stroke [within 30 days after randomisation]
Stroke
Peak potprocedural high-sensitivity troponin T level [within 48 hours after randomisation]
Peak potprocedural high-sensitivity troponin T level
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint) [within 30 days after randomisation]
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deutsches Herzzentrum München	Munich	Bavaria	Germany	80636
2	Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin		Germany	12203
3	Charité - Universitätsmedizin Berlin, Campus Virchow	Berlin		Germany	13353
4	Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie	Frankfurt am Main		Germany	60590
5	Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I	Mainz		Germany	55131
6	Klinikum der Universität München, Medizinische Klinik und Poliklinik I	Munich		Germany	81377
7	Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik	Munich		Germany	81675
8	Universitätsklinikum Tübingen	Tübingen		Germany	72076