Stable Coronary Artery DiseasePhase 2ISAR-PLASTERNCT03312855
Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept
A Phase 2 study testing Revacept 80 mg and Revacept 160 mg in people with Stable Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease
- What is being tested?
- Revacept 80 mg and Revacept 160 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 8 sitesGermany
- Study dates
- 20 Nov 2017to 26 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
Charité - Universitätsmedizin Berlin, Campus Virchow
Berlin, 13353
Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie
Frankfurt am Main, 60590
Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I
Mainz, 55131
Deutsches Herzzentrum München
Munich, Bavaria, 80636
Klinikum der Universität München, Medizinische Klinik und Poliklinik I
Munich, 81377
Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik
Munich, 81675
Universitätsklinikum Tübingen
Tübingen, 72076
About this study
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
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.
Read the 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.
- Conditions
- Stable Coronary Artery Disease
- Being tested
- Revacept 80 mg, Revacept 160 mg, Placebo
- Keywords
- coronary artery disease, platelet inhibition
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revacept 80 mgDrug
single dose, intravenous application of 80 mg Revacept
Revacept 160 mgDrug
single dose, intravenous application of 180 mg Revacept
PlaceboDrug
single dose, intravenous application of Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Revacept 80 mg | Experimental | single dose, intravenous Receives: Drug: Revacept 80 mg |
| Revacept 160 mg | Experimental | single dose, intravenous Receives: Drug: Revacept 160 mg |
| Placebo | Placebo comparator | single dose, intravenous Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 48 hours from randomisation
Secondary outcomes (8)
All cause mortality
All cause mortality
Measured: within 30 days after randomisation
Myocardial infarction
Myocardial infarction
Measured: within 30 days after randomisation
PCI-related (type 4) myocardial infarction
PCI-related (type 4) myocardial infarction
Measured: within 30 days after randomisation
Definite stent thrombosis
Definite stent thrombosis
Measured: within 30 days after randomisation
Urgent coronary revascularization
Urgent coronary revascularization
Measured: within 30 days after randomisation
Stroke
Stroke
Measured: within 30 days after randomisation
Peak potprocedural high-sensitivity troponin T level
Peak potprocedural high-sensitivity troponin T level
Measured: within 48 hours after randomisation
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
Measured: within 30 days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start20 Nov 2017
- Primary completion29 Feb 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- with 2 doses (80 and 160 mg) of Revacept versus placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), AdvanceCor GmbH, Technical University of Munich, German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Adnan Kastrati, MD, Study chair, Deutsches Herzzentrum MünchenSteffen Massberg, MD, Study chair, LMU KlinikumStefanie Schuepke, MD, Study director, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312855
- Sponsor's protocol ID
- Revacept/CAD/02
- Acronym
- ISAR-PLASTER
- Status last verified
- Apr 2020
- First submitted
- 13 Oct 2017
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33787834
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03312855
- Acronym / sponsor ID
- ISAR-PLASTER / Revacept/CAD/02
- Conditions
- Stable Coronary Artery Disease
- Keywords
- coronary artery disease, platelet inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), AdvanceCor GmbH, Technical University of Munich, German Federal Ministry of Education and Research
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- with 2 doses (80 and 160 mg) of Revacept versus placebo
| Arm | Type | Receives |
|---|---|---|
| Revacept 80 mg | Experimental | Drug: Revacept 80 mgsingle dose, intravenous |
| Revacept 160 mg | Experimental | Drug: Revacept 160 mgsingle dose, intravenous |
| Placebo | Placebo comparator | Drug: Placebosingle dose, intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revacept 80 mgsingle dose, intravenous application of 80 mg Revacept | Drug | Revacept 80 mg |
| Revacept 160 mgsingle dose, intravenous application of 180 mg Revacept | Drug | Revacept 160 mg |
| Placebosingle dose, intravenous application of Placebo solution | Drug | Placebo |
Primary outcome
Primary endpoint-composite endpoint of death and myocardial injury
Time frame: 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).
8 secondary outcomes
All cause mortality
Time frame: within 30 days after randomisation
Myocardial infarction
Time frame: within 30 days after randomisation
PCI-related (type 4) myocardial infarction
Time frame: within 30 days after randomisation
Definite stent thrombosis
Time frame: within 30 days after randomisation
Urgent coronary revascularization
Time frame: within 30 days after randomisation
Stroke
Time frame: within 30 days after randomisation
Peak potprocedural high-sensitivity troponin T level
Time frame: within 48 hours after randomisation
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
Time frame: within 30 days after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 33787834Mayer 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.
- Individual participant dataSharing planned: No
Related trials for Stable Coronary Artery Disease
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
RecruitingPhase 4
Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
Atrial Fibrillation (AF), Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Kastrati, MD study chair
Deutsches Herzzentrum München
Steffen Massberg, MD study chair
LMU Klinikum
Stefanie Schuepke, MD study director
Deutsches Herzzentrum Muenchen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Revacept 80 mg and Revacept 160 mg in people with Stable Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint-composite endpoint of death and myocardial injury (time frame: within 48 hours from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.