DUAL Antithrombotic Therapy in Patients With AF and ACS

NCT04023630 | Unknown Phase 4 DMC

• 1 other identifier: SAHZJU CT013
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

Conditions

Atrial Fibrillation; Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (1)

• The composite endpoints of death and ischemic events

  The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )

  one year

Secondary Outcomes (1)

• Clinically significant bleeding

  one year

Study Arms (2)

rivaroxaban plus ticagrelor

EXPERIMENTAL

rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months

Drug: Rivaroxaban 15 MG Oral Tablet; Drug: Ticagrelor 90 MG Oral Tablet

rivaroxaban plus clopidogrel

ACTIVE COMPARATOR

rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months

Drug: Rivaroxaban 15 MG Oral Tablet; Drug: Clopidogrel 75 Mg Oral Tablet

Interventions

Rivaroxaban 15 MG Oral Tablet DRUG

One 15 mg tablet once daily for up to twelve months

Also known as: Xarelto

rivaroxaban plus clopidogrel; rivaroxaban plus ticagrelor

Clopidogrel 75 Mg Oral Tablet DRUG

One 75 mg tablet once daily for up to twelve months

Also known as: P2Y12 antagonists

rivaroxaban plus clopidogrel

Ticagrelor 90 MG Oral Tablet DRUG

One 90 mg tablet twice daily for up to twelve months

Also known as: P2Y12 antagonists

rivaroxaban plus ticagrelor

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome
• Planned use of antiplatelet agents for at least 12 months
• Males and Females ≥ 18 years of age
• Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

You may not qualify if:

• Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
• Severe renal insufficiency (serum creatinine \> 2.5 mg/dL or a calculated creatinine clearance \< 30 mL/min
• Patients with a history of intracranial hemorrhage
• Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
• Patients with known ongoing bleeding and patients with known coagulopathies
• Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists
• Have a history of stroke or Transient Ischemic Attack (TIA)
• Have known significant liver disease or liver function test (LFT) abnormalities
• Have any severe condition that would limit life expectancy to less than 12 months

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Atrial Fibrillation; Acute Coronary Syndrome

Interventions

Rivaroxaban; Tablets; Clopidogrel; Purinergic P2Y Receptor Antagonists; Ticagrelor

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jun Jiang, PhD

  Second Affiliated Hospital Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Jun Jiang, PhD

CONTACT

13588706891; hu888po@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 17, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: July 17, 2019

Record last verified: 2019-07