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Simplified Anti-Thrombotic Therapy for FFR (SMART-FFR)

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ClinicalTrials.gov Identifier: NCT02384070
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Fernando Boccalandro MD, Odessa Heart Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Interventions Procedure: FFR
Drug: Aspirin
Drug: Clopidogrel
Drug: Bivalirudin
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Upstream Aspirin + Clopidrogel Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin Group 3: Upstream Aspirin Plus Bivalirudin
Hide Arm/Group Description 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 Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
Period Title: Overall Study
Started 100 100 100
Completed 100 100 100
Not Completed 0 0 0
Arm/Group Title Group 1: Upstream Aspirin + Clopidrogel Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin Group 3: Upstream Aspirin Plus Bivalirudin Total
Hide Arm/Group Description

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 100 100 100 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 100 participants 300 participants
62  (9) 65  (10) 63  (8) 64  (3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 100 participants 300 participants
Female
38
  38.0%
39
  39.0%
35
  35.0%
112
  37.3%
Male
62
  62.0%
61
  61.0%
65
  65.0%
188
  62.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 100 participants 100 participants 300 participants
100 100 100 300
1.Primary Outcome
Title Thrombotic Complications
Hide Description [Not Specified]
Time Frame Hospital Stay and after 30 days post PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Number of Patients
0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments The prior threshold for statistical significance was P < 0.05
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores
Hide Description
  1. Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.
  2. Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention
Time Frame Hospital Stay and after 30 days post PCI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Patients
1 3 1
3.Secondary Outcome
Title Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure
Hide Description [Not Specified]
Time Frame 48 hours post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Group 1 Group 2 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Group 1 Group 2 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fernando Boccalandro MD FACC FSCAI
Organization: Odessa Heart Institute / Permian Research Foundation
Phone: 432-3373117
EMail: Fboccalandro@echd.org
Layout table for additonal information
Responsible Party: Fernando Boccalandro MD, Odessa Heart Institute
ClinicalTrials.gov Identifier: NCT02384070     History of Changes
Other Study ID Numbers: 20095
First Submitted: February 22, 2015
First Posted: March 10, 2015
Results First Submitted: April 10, 2016
Results First Posted: February 3, 2017
Last Update Posted: February 3, 2017