To Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome

Phase 4

Not yet recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Rivaroxaban 2.5 Mg Oral Tablet; Drug: Clopidogrel tablet; Drug: Aspirin tablet

• Registration Number: NCT05573958
• Lead Sponsor: Sarmad Zahoor

Brief Summary

Direct-acting oral anticoagulants (DOACs) have provided benefits to patients requiring anticoagulation for certain diseases by decreasing the burden of subcutaneous injections and the requirement for frequent monitoring through regular blood tests. DOACs do not require monitoring, have a more predictable pharmacokinetic (dosing) profile and have fewer interactions with other drugs. Various studies have reported the efficacy and safety of different dual-acting anticoagulants around the globe. However, there is little data available from Pakistan. Therefore, investigators propose this study to assess the efficiency and safety of rivaroxaban and clopidogrel along with aspirin in patients suffering from acute coronary syndrome. The objective of this study is to investigate the efficacy of dual anticoagulants i.e. aspirin plus rivaroxaban versus aspirin plus clopidogrel in patients suffering from acute coronary syndrome in terms of secondary prophylaxis. All the patient records will be documented in Case Report Form (CRF) at each visit. All data will be recorded in individual source documents. All CRF information is to be filled in by site staff. If an item is not available or is not applicable, this fact should be indicated. Blank spaces should not be present unless otherwise directed. The study monitor will perform source data verification of data entered into the CRF. The data entered into the CRF will be subject to data validation checks for consistency and completeness by the data management group. All CRFs should be maintained on the system with details of any changes logged accordingly.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10
• Primary Completion: 2023-03-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Male and female aged ≥ 18 years and above
• Participants able to understand the study procedures and willing to give written informed consent/assent to participate in the trial
• Participants willing to follow the study procedures of the study and available for the entire duration of the study.
• Female participants of childbearing potential must have a negative urine pregnancy test
• Women of childbearing potential (WOCBP) must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 90 days following the final dose of study treatment, to avoid pregnancy. (This is in line with regulatory Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals)

Exclusion Criteria

• Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
• Arrhythmias
• Pre-existing hepatic disease
• Pre-existing renal disease
• Already taking any drug
• Pregnancy
• Thyroid dysfunctions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Rivaroxaban, Clopidogrel, and Aspirin	Clopidogrel tablet	Rivaroxaban 2.5 mg tablet twice daily orally, Clopidogrel 75 mg tablet once daily orally, and Aspirin 81 mg tablet once daily
Arm A: Rivaroxaban, Clopidogrel, and Aspirin	Aspirin tablet	Rivaroxaban 2.5 mg tablet twice daily orally, Clopidogrel 75 mg tablet once daily orally, and Aspirin 81 mg tablet once daily
Arm B: Clopidogrel and Aspirin	Clopidogrel tablet	Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily
Arm B: Clopidogrel and Aspirin	Aspirin tablet	Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily
Arm A: Rivaroxaban, Clopidogrel, and Aspirin	Rivaroxaban 2.5 Mg Oral Tablet	Rivaroxaban 2.5 mg tablet twice daily orally, Clopidogrel 75 mg tablet once daily orally, and Aspirin 81 mg tablet once daily

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events (MACE)	3 months	Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death