Acute Coronary SyndromePhase 4ACCPNCT05573958
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
A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet, Clopidogrel tablet and Aspirin tablet in people with Acute Coronary Syndrome, run by Sarmad Zahoor.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Rivaroxaban 2.5 Mg Oral Tablet, Clopidogrel tablet and Aspirin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Rivaroxaban 2.5 Mg Oral Tablet, Clopidogrel tablet, Aspirin tablet
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 Mg Oral TabletDrug
Also called Xarelto
Rivaroxaban 2.5 mg oral tablet will be administered twice daily
Clopidogrel tabletDrug
Also called Plavix
Clopidogrel 75 mg once daily orally
Aspirin tabletDrug
Also called Acetylsalicylic acid
Aspirin 81 mg tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Rivaroxaban, Clopidogrel, and Aspirin | Experimental | Rivaroxaban 2.5 mg tablet twice daily orally, Clopidogrel 75 mg tablet once daily orally, and Aspirin 81 mg tablet once daily Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet; Drug: Clopidogrel tablet; Drug: Aspirin tablet |
| Arm B: Clopidogrel and Aspirin | Active comparator | Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily Receives: Drug: Clopidogrel tablet; Drug: Aspirin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarmad Zahoor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Management and Technology Lahore, Mayo Hospital Lahore
- Responsible party
- Sponsor-investigator, Sarmad Zahoor, Punjab Institute of Cardology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573958
- Sponsor's protocol ID
- PIC-2022-06
- Acronym
- ACCP
- Status last verified
- Oct 2022
- First submitted
- 9 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05573958
- Acronym / sponsor ID
- ACCP / PIC-2022-06
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sarmad ZahoorUniversity, hospital or other
- Collaborators
- University of Management and Technology Lahore, Mayo Hospital Lahore
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Rivaroxaban, Clopidogrel, and Aspirin | Experimental | Drug: Rivaroxaban 2.5 Mg Oral Tablet, Drug: Clopidogrel tablet, Drug: Aspirin tabletRivaroxaban 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 | Active comparator | Drug: Clopidogrel tablet, Drug: Aspirin tabletClopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias
- Pre-existing hepatic disease
- Pre-existing renal disease
- Already taking any drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 Mg Oral TabletAlso: XareltoRivaroxaban 2.5 mg oral tablet will be administered twice daily | Drug | Arm A: Rivaroxaban, Clopidogrel, and Aspirin |
| Clopidogrel tabletAlso: PlavixClopidogrel 75 mg once daily orally | Drug | Arm A: Rivaroxaban, Clopidogrel, and Aspirin, Arm B: Clopidogrel and Aspirin |
| Aspirin tabletAlso: Acetylsalicylic acidAspirin 81 mg tablet once daily | Drug | Arm A: Rivaroxaban, Clopidogrel, and Aspirin, Arm B: Clopidogrel and Aspirin |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 3 months
Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet, Clopidogrel tablet and Aspirin tablet in people with Acute Coronary Syndrome, run by Sarmad Zahoor.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sarmad Zahoor, MBBS (03336431557, drsarmadzahoor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.