Coronary Artery DiseasePhase 4RE-DUAL PCINCT04688723

Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

A Phase 4 study testing Dabigatran + Ticagrelor and Dabigatran + clopidogrel in people with Coronary Artery Disease and Myocardial Ischemia, run by Zuyderland Medisch Centrum at 1 site in Netherlands.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
What is being tested?: Dabigatran + Ticagrelor and Dabigatran + clopidogrel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteNetherlands
Study dates: 23 Dec 2020to 1 Jul 2023
Phase: Phase 4
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible.
PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI)
Written informed consent.

Who cannot join

Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study
Glomerular filtration rate < 30 ml/min
Heart valve prosthesis (mechanical or biological)
Cardiogenic shock
Contra-indication for Dabigatran, Ticagrelor or Clopidogrel
Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C)

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Lesion or condition with a significant risk of serious bleeding, such as; current or recent gastrointestinal ulceration; malignant neoplasms with more bleeding risk; recent brain / spinal cord injury; recent surgery on the brain, spinal cord or eyes; recent or history of intracranial haemorrhage; oesophageal varices; arteriovenous malformations; vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities.
comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan's wort or phenytoin o Comedication with tacrolimus is not recommended.
Allergy to for Dabigatran, Ticagrelor or Clopidogrel
Pregnancy
Significant thrombocytopenia (platelet count < 50x10 9/L)
Major bleeding according to BARC ≥3 within the past 6 months.
Weight < 50 kg

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting

Zuyderland MC
Heerlen, Limburg, 6419PC
Patty Winkler, +31 6 53368084, p.winkler@zuyderland.nl
Jasper Luijkx
Recruiting

Other trials in Netherlands

About this study

Official title: RE-DUAL PCI Real Life Registry Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

A real world registry to compare dual therapy with Dabigatran/Ticagrelor to dual therapie with Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with Dabigatran/Ticagrelor will be non-inferior in reducing the risk of bleeding compared to Dual therapy with Dabigatran/Clopidogrel (RE-DUAL PCI trial based) in patients with an indication for NOAC undergoing PCI in the setting of ACS. Thromboembolic events, stent thrombosis and death will be evaluated for estimation of events between both groups. Data will be pooled for this secondary endpoint with data from the upcoming WOEST-3 trial to compare both treatments.

Read the detailed description

The REDUAL PCI Registry will we be an open-label multicenter registry based randomised controlled trial (RBRCT) within the ZON-HR collaboration in 4 of the 6 centers in the Netherlands: Maastricht Universitair Medisch Centrum (Maastricht), Zuyderland (Heerlen and Sittard), Vie Curi (Venlo) and Radboud Medisch Centrum (Nijmegen). Isala (Zwolle) and Canisius Wilhelmina ziekenhuis (Nijmegen) will not be part of this study. This study is Investigator initiated with an unrestricted grant from Boehringer Ingelheim (subsidising party). This study is also to be noted as a Post Authorisation Safety Study (PASS). Patients 1000 patients with an indication for NOAC, who underwent successful PCI with Drug Eluting Stent (DES) in the setting of ACS will be included and randomised at each of the 4 centers of the ZON-HR. After randomisation, patients will be treated with Dual therapy with Dabigatran/Clopidogrel or with Dabigatran/ Ticagrelor. A total of 1000 patients in 4 centers will be included: 250 patients in each center. In each center inclusion and randomisation will be executed within 48 hours after PCI. Inclusions are expected to be done within 1 year. After inclusion of the interventional (Dual therapy with Dabigatran/Ticagrelor) and control group (Dual therapy with Dabigatran/Clopidogrel), follow-up of 1 year is planned.

Conditions: Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Atrial Fibrillation
Being tested: Dabigatran + Ticagrelor, Dabigatran + clopidogrel
Medical subject headings: Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Atrial Fibrillation

What participants receive

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

Dabigatran + TicagrelorDrug
Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.
Dabigatran + clopidogrelDrug
Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.

Study groups in NCT04688723
Study group	Role	What they receive
Dabigatran/Clopidogrel	Active comparator	Patiënt receive standard care, with dabigatran + clopidogrel 75mg once daily up to 12 months. Receives: Drug: Dabigatran + clopidogrel
Dabigatran/Ticagrelor	Experimental	Patiënt receive standard care, with dabigatran + ticagrelor 90mg twice daily up to 12 months. Receives: Drug: Dabigatran + Ticagrelor

What is being measured

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

Bleeding
Bleeding defined as BARC bleeding score ≥2
Measured: 12 months

Secondary outcomes (5)

Myocardial Infarction
Myocardial Infarction
Measured: 12 months
Cerebrovascular accident
Cerebrovascular accident, ischemic of haemorrhagic
Measured: 12 months
Systemic Embolic Complications
Systemic Embolic Complications
Measured: 12 months
Death
Death
Measured: 12 months
Combined endpoint of ischemic events
All secondary outcomes combined into one endpoint
Measured: 12 months

Timeline

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

23 Dec 20201 Jul 2023

First posted30 Dec 2020
Study start23 Dec 2020
Primary completion31 Dec 2022 (estimated)
Study completion1 Jul 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04688723
Sponsor's protocol ID: METCZ20200196
Acronym: RE-DUAL PCI
Status last verified: Dec 2020
First submitted: 23 Dec 2020
Last updated: 30 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RE-DUAL PCI Real Life Registry Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI
ClinicalTrials.gov ID: NCT04688723
Acronym / sponsor ID: RE-DUAL PCI / METCZ20200196
Conditions: Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,000 participants (estimated)
Lead sponsor: Zuyderland Medisch CentrumUniversity, hospital or other
Collaborators: Boehringer Ingelheim
Study start: 23 Dec 2020 (actual)
Primary completion: 31 Dec 2022 (estimated)
Study completion: 1 Jul 2023 (estimated)
First posted: 30 Dec 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dabigatran/Clopidogrel	Active comparator	Drug: Dabigatran + clopidogrelPatiënt receive standard care, with dabigatran + clopidogrel 75mg once daily up to 12 months.
Dabigatran/Ticagrelor	Experimental	Drug: Dabigatran + TicagrelorPatiënt receive standard care, with dabigatran + ticagrelor 90mg twice daily up to 12 months.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18 years
Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible.
PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI)
Written informed consent.

Key exclusion criteria (13 listed)

Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study
Glomerular filtration rate < 30 ml/min
Heart valve prosthesis (mechanical or biological)
Cardiogenic shock
Contra-indication for Dabigatran, Ticagrelor or Clopidogrel

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
Dabigatran + TicagrelorPatiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.	Drug	Dabigatran/Ticagrelor
Dabigatran + clopidogrelPatiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.	Drug	Dabigatran/Clopidogrel

Primary outcome

Bleeding
Time frame: 12 months
Bleeding defined as BARC bleeding score ≥2

5 secondary outcomes

Myocardial Infarction
Time frame: 12 months
Cerebrovascular accident
Time frame: 12 months
Systemic Embolic Complications
Time frame: 12 months
Death
Time frame: 12 months
Combined endpoint of ischemic events
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Individual participant dataSharing planned: No

Related trials for Coronary Artery Disease

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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.

Zuyderland MC

Heerlen, Netherlands

+31 6 53368084

p.winkler@zuyderland.nl

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding (time frame: 12 months). 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 NCT04688723.

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 30 Apr 2021.