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 (ACCP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Rivaroxaban 2.5 Mg Oral Tablet; Drug: Clopidogrel tablet; Drug: Aspirin tablet

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. Sarmad Zahoor, MBBS; Phone Number: 03336431557; Email: drsarmadzahoor@gmail.com
• Study Contact Backup: Name: Dr. Muhammad Sajid Jehangir, MBBS, FCPS; Phone Number: 03456610346; Email: sajidroomi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Rivaroxaban, Clopidogrel, and Aspirin; 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; Rivaroxaban 2.5 mg oral tablet will be administered twice daily; Other Names: Xarelto; Drug: Clopidogrel tablet; Clopidogrel 75 mg once daily orally; Other Names: Plavix; Drug: Aspirin tablet; Aspirin 81 mg tablet once daily; Other Names: Acetylsalicylic acid
Active Comparator: Arm B: Clopidogrel and Aspirin; Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily	Drug: Clopidogrel tablet; Clopidogrel 75 mg once daily orally; Other Names: Plavix; Drug: Aspirin tablet; Aspirin 81 mg tablet once daily; Other Names: Acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sarmad Zahoor
• Collaborators: Mayo Hospital Lahore; University of Managemant and Technology, Pakistan

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Clopidogrel; Rivaroxaban
• Other Study ID Numbers: PIC-2022-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No