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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03312855

Acronym

ISAR-PLASTER

Enrollment

334

Registered

2017-10-18

Start date

2017-11-20

Completion date

2020-03-26

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Coronary Artery Disease

Keywords

coronary artery disease, platelet inhibition

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.

Interventions

DRUGRevacept 80 mg

single dose, intravenous application of 80 mg Revacept

DRUGRevacept 160 mg

single dose, intravenous application of 180 mg Revacept

DRUGPlacebo

single dose, intravenous application of Placebo solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
All cause mortality	within 30 days after randomisation	All cause mortality
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)
Urgent coronary revascularization	within 30 days after randomisation	Urgent coronary revascularization

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026