ACCP: 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

Sponsor
Sarmad Zahoor (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05573958
Collaborator
University of Managemant and Technology, Pakistan (Other), Mayo Hospital Lahore (Other)
90
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rivaroxaban 2.5 Mg Oral Tablet
  • Drug: Clopidogrel tablet
  • Drug: Aspirin tablet
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Major Adverse Cardiovascular Events (MACE) [3 months]

      Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sarmad Zahoor
    • University of Managemant and Technology, Pakistan
    • Mayo Hospital Lahore

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarmad Zahoor, Resident, Punjab Institute of Cardology
    ClinicalTrials.gov Identifier:
    NCT05573958
    Other Study ID Numbers:
    • PIC-2022-06
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2022