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

NCT04688723 | Unknown Phase 4 DMC

• 1 other identifier: METCZ20200196
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Bleeding

  Bleeding defined as BARC bleeding score ≥2

  12 months

Secondary Outcomes (5)

• Myocardial Infarction

  12 months

• Cerebrovascular accident

  12 months

• Systemic Embolic Complications

  12 months

• Death

  12 months

• Combined endpoint of ischemic events

  12 months

Study Arms (2)

Dabigatran/Clopidogrel

ACTIVE COMPARATOR

Patiënt receive standard care, with dabigatran + clopidogrel 75mg once daily up to 12 months.

Drug: Dabigatran + clopidogrel

Dabigatran/Ticagrelor

EXPERIMENTAL

Patiënt receive standard care, with dabigatran + ticagrelor 90mg twice daily up to 12 months.

Drug: Dabigatran + Ticagrelor

Interventions

Dabigatran + Ticagrelor DRUG

Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.

Dabigatran/Ticagrelor

Dabigatran + clopidogrel DRUG

Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.

Dabigatran/Clopidogrel

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Zuyderland MC

Heerlen, Limburg, 6419PC, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Atrial Fibrillation

Interventions

Dabigatran; Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 30, 2020
• Study Start: December 23, 2020
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: April 30, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)