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Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR calculation, no study has evaluated the optimal anti-thrombotic regimen in patients undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in patients with intermediate coronary artery stenosis undergoing FFR calculation during elective coronary angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator |
|
| Group 2 | Active Comparator | Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation |
|
| Group 3 | Experimental | Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR | Procedure | Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80. |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic Complications | Hospital Stay and after 30 days post PCI |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores |
|
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Upstream Aspirin + Clopidrogel | Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator |
| FG001 | Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin | Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation |
| FG002 | Group 3: Upstream Aspirin Plus Bivalirudin | Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Upstream Aspirin + Clopidrogel | Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure |
| BG001 | Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thrombotic Complications | Posted | Number | Number of Patients | Hospital Stay and after 30 days post PCI |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Boccalandro MD FACC FSCAI | Odessa Heart Institute / Permian Research Foundation | 432-3373117 | Fboccalandro@echd.org |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053805 | Fractional Flow Reserve, Myocardial |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| C074619 | bivalirudin |
| ID | Term |
|---|---|
| D003326 | Coronary Circulation |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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|
|
| Aspirin | Drug | All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure |
|
| Clopidogrel | Drug | All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure |
|
| Bivalirudin | Drug | Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure |
|
| Hospital Stay and after 30 days post PCI |
| Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure | 48 hours post procedure |
Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure |
| BG002 | Group 3: Upstream Aspirin Plus Bivalirudin | Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group 3 | Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure |
|
|
|
| Secondary | TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores |
| Posted | Number | Patients | Hospital Stay and after 30 days post PCI |
|
|
|
| Secondary | Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure | Posted | Number | participants | 48 hours post procedure |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Group 2 | Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure | 0 | 100 | 0 | 100 |
| EG002 | Group 3 | Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure | 0 | 100 | 0 | 100 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |