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Angina, StableCOBRA-REDUCENCT02594501

Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

A study testing COBRA PzF and Drug Eluting Stent in people with Angina, Stable and Angina, Unstable, run by CeloNova BioSciences, Inc. at 48 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angina, Stable, Angina, Unstable, Anticoagulants
What is being tested?
COBRA PzF and Drug Eluting Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
996 participants
Where
48 sitesin 8 countries
Study dates
5 Feb 2016to Nov 2021
Phase
Interventional
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

  • Patients older than age 18 with ischemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in one or 2 separate vessels).
  • Patient receiving or with an indication for new treatment with long-term oral anticoagulation with a coumadin derivatives or non-vitamin K oral anticoagulants.
  • Written, informed consent

Who cannot join

  • Cardiogenic shock
  • Target lesion located in left main trunk
  • Bifurcation interventions with a planned 2-stent strategy
  • Vessel size too small for implantation of a 2.5 mm stent by visual estimation
  • Patient requiring staging PCI procedure within 6 months after the index procedure
  • Patients requiring DAPT for more than 2 weeks after the index procedure
Show all 13Show fewer
  • Contraindications or allergy to cobalt, chromium, platinum, polyzene-F, everolimus, zotarolimus or the inability to take triple therapy for at least 6 months
  • Relevant hematologic deviations: platelet count <100x10^9 cells/L or >600x10^9 cells/L
  • Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection
  • Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
  • Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
  • Known allergy or intolerance to the study medications: ASA, clopidogrel, coumadin and its derivatives
  • Patient's inability to fully cooperate with the study protocol

Trial locations and contacts

48 sites in 8 countries.

48 sites in 8 countries

United States22 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • North Ohio Heart Center

    Elyria, Ohio, 44035

  • Cleveland Clinic

    Fairview Park, Ohio, 44126

  • University of Florida

    Jacksonville, Florida, 32209

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216

  • Texas Cardiac Center

    Lubbock, Texas, 79410

  • Northwell Health

    Manhasset, New York, 11030

  • Sebastian River Medical Center

    Melbourne, Florida, 32901

  • Mt Sinai Medical Center

    Miami Beach, Florida, 33140

  • NYU Winthrop Hospital

    Mineola, New York, 11501

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Rutgers Robert Wood Johnson Medical Schoo

    New Brunswick, New Jersey, 08901

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Sentara Heart Hospital (Sentara Cardiovascular Research Institute)

    Norfolk, Virginia, 23507

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Carilion Medical Center

    Roanoke, Virginia, 24014

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • University of Maryland St. Joseph Medical Center

    Towson, Maryland, 21204

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

Other trials in United States

Germany13 sites

  • Universitats Herzzentrum Freibourg

    Bad Krozingen, 79819

  • Charité - Campus Benjamin Franklin

    Berlin, 12203

  • Uni-Klinikum Erlangen

    Erlangen

  • St. Josefskrankenhaus

    Freiburg im Breisgau

  • Klinikum Fürth

    Fürth

  • University of Jena

    Jena

  • MediClin Herzzentrum

    Lahr

  • Klinikum Landshut-Achdorf

    Landshut

  • Deutsches Herzzentrum München

    Munich

  • Klinikum Rechts der Isar München

    Munich

  • Universitätsklinikum Regensburg

    Regensburg

  • Hegau Bodensee Klinikum Singen

    Singen

  • Univesitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

France7 sites

  • Clinique Axium

    Aix

  • Clinique Du Pont De Chaumes

    Montauban

  • Clinique du Millénaire

    Montpellier, 34000

  • Hopital Pitie-Salpitierre

    Paris, 75013

  • Höpital George Pompidou

    Paris

  • Clinique Pasteur

    Toulouse, 31300

  • Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois

    Vandœuvre-lès-Nancy

Other trials in France

Switzerland2 sites

  • Hopital Cantonal Fribourg

    Fribourg

  • Kantonspital St Galen

    Sankt Gallen

Other trials in Switzerland

Belgium1 site

  • ZNA Middelheim

    Antwerp, 2020

Other trials in Belgium

Denmark1 site

  • Aarhus University Hospital

    Aarhus

Other trials in Denmark

Italy1 site

  • Ospedale Spaziani

    Frosinone

Other trials in Italy

Latvia1 site

  • Paula Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

About this study

Official title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

Being tested
COBRA PzF, Drug Eluting Stent
Medical subject headings
Angina, Stable, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COBRA PzFDevice

  • Drug Eluting StentDevice

    Also called Xience/Promus, Resolute or Synergy

Study groups in NCT02594501
Study groupRoleWhat they receive
COBRA PzFExperimentalCobra PzF plus 14-day DAPT (dual antiplatelet therapy)
Receives: Device: COBRA PzF
Drug Eluting StentActive comparatorstandard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)
Receives: Device: Drug Eluting Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").

    Measured: 6 months

  2. Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke

    Measured: 6 months

Secondary outcomes (9)

  1. Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke

    Measured: 12 months

  2. Composite of cardiac death and myocardial infarction

    Measured: 12 months

  3. Ischemia driven target lesion revascularization

    Measured: 12 months

  4. Definite and probable stent thrombosis

    Measured: 12 months

  5. Ischemic stroke

    Measured: 12 months

  6. BARC class 3-5 bleeding

    Measured: 6 months

  7. TIMI major bleeding; TIMI major and minor bleeding

    Measured: 6 months

  8. Acute Success Rates

    Device success; Lesion success; Procedure success

    Measured: procedure

  9. Health economic utility

    Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2015 (estimated)
  2. Study start5 Feb 2016
  3. Primary completionMay 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
996 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02594501
Sponsor's protocol ID
COBRA 2015-01
Acronym
COBRA-REDUCE
Status last verified
Oct 2020
First submitted
30 Oct 2015
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bresha J, Hug KP, Byrne RA, Lahu S, Cassese S, Colleran R, Ibrahim T, Xhepa E, Bernlochner I, Joner M, Laugwitz KL, Kastrati A, Kufner S, Coughlan JJ; COBRA-REDUCE investigators. Long term follow up of patients treated with a polymer coated non drug-eluting stent in the COBRA-REDUCE trial. Cardiovasc Revasc Med. 2025 Jun;75:15-22. doi: 10.1016/j.carrev.2025.02.014. Epub 2025 Mar 2.

    PubMed 40050141

  • Byrne RA, Colleran R, Coughlan JJ, Jauhar R, Maillard L, De Labriolle A, Maeng M, Croft C, Brunner M, Leistner D, Zrenner B, Kollum M, Laugwitz KL, Xhepa E, Mayer K, Lahu S, Joner M, Kirtane A, Mehran R, Barakat M, Urban P, Cutlip DE, Kastrati A; COBRA-REDUCE Investigators. Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial. Circ Cardiovasc Interv. 2024 Oct;17(10):e013735. doi: 10.1161/CIRCINTERVENTIONS.123.013735. Epub 2024 Oct 15.

    PubMed 39405373

  • Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2022 Jan;34:17-24. doi: 10.1016/j.carrev.2021.01.022. Epub 2021 Jan 22.

    PubMed 33608239

Questions about this trial

What is this clinical trial studying?

A study testing COBRA PzF and Drug Eluting Stent in people with Angina, Stable and Angina, Unstable, run by CeloNova BioSciences, Inc. at 48 sites in 8 countries.

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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Germany, France, Switzerland, Belgium and 3 more countries. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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?

BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later"). (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02594501, which also lists 3 linked publications.

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 26 Oct 2020.

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