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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04023630
Other study ID # SAHZJU CT013
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 1, 2019
Est. completion date September 30, 2021

Study information

Verified date July 2019
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Jun Jiang, PhD
Phone 13588706891
Email hu888po@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4000
Est. completion date September 30, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

1. 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

2. Planned use of antiplatelet agents for at least 12 months

3. Males and Females = 18 years of age

4. Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

1. Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)

2. Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min

3. Patients with a history of intracranial hemorrhage

4. Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event

5. Patients with known ongoing bleeding and patients with known coagulopathies

6. Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists

7. Have a history of stroke or Transient Ischemic Attack (TIA)

8. Have known significant liver disease or liver function test (LFT) abnormalities

9. Have any severe condition that would limit life expectancy to less than 12 months

Study Design


Intervention

Drug:
Rivaroxaban 15 MG Oral Tablet
One 15 mg tablet once daily for up to twelve months
Clopidogrel 75 Mg Oral Tablet
One 75 mg tablet once daily for up to twelve months
Ticagrelor 90 MG Oral Tablet
One 90 mg tablet twice daily for up to twelve months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Clinically significant bleeding Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA) one year
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