REVACEPT ISAR-PLASTER


Study information
REVACEPT ISAR-PLASTER

Recruiting status

Study completed

Recruitment start

11/2017

Patients

332

332

Clinical Trials Registration

NCT03312855

Category

Early clinical study

DZHK Funding

EUR 990.152,29

Operative contact:
Main study centre - Marion Janisch, MD
janischm@dhm.mhn.de

Revacept, a novel inhibitor of platelet adhesion in patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (ISAR-PLASTER)

The coronary vessels are blocked in coronary heart disease. If physicians dilate the vessels with a catheter, the deposits (plaques) can tear and damage the walls of the blood vessels. Such small damages are a risk factor for circulatory disorders and heart attacks, as platelets can adhere to these sites and clots can form. Patients therefore receive blood thinning drugs that prevent platelet accumulation during the procedure. The disadvantage of the drugs used to date is that they also increase the risk of potentially life threatening bleedings, because they inhibit a central step of haemostasis, or platelet accumulation, in the entire body. The purpose of the study is to investigate whether the new antiplatelet drug Revacept reduces the formation of blood clots during cardiac catheterisation without increasing the bleeding risk. In comparison to conventional blood thinners, Revacept only binds to the damaged sites in the vessel and shields them so that no platelets can accumulate there.

Years of intensive basic research showed how platelets adhere to damaged vessel sites, preceded the development of Revacept. Scientists focused on the adhesion of platelets to the collagen that only protrudes into the blood stream where vessel walls are damaged. The agent Revacept binds to the collagen of the damaged sites in a targeted manner and thus prevents the adhesion of platelets.

Revacept was further developed into a drug for use in humans by the biotech company advanceCOR. A previous study with healthy volunteers has already proven that Revacept is safe and well tolerated. 330 patients with a coronary heart disease for whom a catheterisation is planned will be examined in this study. Some patients will be treated with Revacept in addition to the usual medication. During the study, bleeding risk will be monitored and a marker in the blood will be used to investigate whether Revacept sufficiently prevents circulatory disorders in the heartdamage of the heart muscle.

Publications

Mayer K. et al. 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; PMCID: PMC8014195.

Further publications can be found here

Principal Investigators

Prof. Dr. Steffen Massberg
Klinikum der Universität München / Klinikum Großhadern
Prof. Dr. med. Adnan Kastrati
Deutsches Herzzentrum München

Press releases and news

DZHK Study: Plaster against blood clots

A new clinical study is starting at the German Centre for Cardiovascular Research (DZHK) with an...

Innovative platelet inhibitor tested for the first time in cardiovascular patients (Study REVACEPT ISAR-PLASTER)

Revacept is a novel platelet inhibitor that binds specifically to injured blood vessels and can be...