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| Name | Class |
|---|---|
| University of Management and Technology Lahore | OTHER |
| Mayo Hospital Lahore | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Arm B: Clopidogrel and Aspirin | Active Comparator | Clopidogrel 75 mg tablet once daily, and Aspirin 81 mg tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 2.5 Mg Oral Tablet | Drug | Rivaroxaban 2.5 mg oral tablet will be administered twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | Myocardial infarction, Arrhythmia, Stroke, Pulmonary Edema, Death | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarmad Zahoor, MBBS | Contact | 03336431557 | drsarmadzahoor@gmail.com | |
| Dr. Muhammad Sajid Jehangir, MBBS, FCPS | Contact | 03456610346 | sajidroomi@gmail.com |
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| Clopidogrel tablet | Drug | Clopidogrel 75 mg once daily orally |
|
|
| Aspirin tablet | Drug | Aspirin 81 mg tablet once daily |
|
|
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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