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

Study Overview
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Brief Summary
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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.

Official Title
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Open-label Randomized Control Trial 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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Rivaroxaban 2.5 Mg Oral Tablet
* Drug: Clopidogrel tablet
* Drug: Aspirin tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Rivaroxaban, Clopidogrel, and Aspirin<br>Rivaroxaban 2.5 mg tablet twice daily orally, Clopidogrel 75 mg tablet once daily orally, and Aspirin 81 mg tablet once daily | Drug: Rivaroxaban 2.5 Mg Oral Tablet<br>* Rivaroxaban 2.5 mg oral tablet will be administered twice daily<br>* Other names: Xarelto;Drug: Clopidogrel tablet<br>* Clopidogrel 75 mg once daily orally<br>* Other names: Plavix;Drug: Aspirin tablet<br>* Aspirin 81 mg tablet once daily<br>* Other names: Acetylsalicylic acid;|
| Active Comparator: Arm B: Clopidogrel and Aspirin<br>Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily | Drug: Clopidogrel tablet<br>* Clopidogrel 75 mg once daily orally<br>* Other names: Plavix;Drug: Aspirin tablet<br>* Aspirin 81 mg tablet once daily<br>* Other names: Acetylsalicylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events (MACE) | Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death | 3 months |