Trial Outcomes & Findings for Simplified Anti-Thrombotic Therapy for FFR (NCT NCT02384070)

NCT ID: NCT02384070

Last Updated: 2017-02-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: Hospital Stay and after 30 days post PCI
• Results posted on: 2017-02-03

Participant Flow

Participant milestones

Measure	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	Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation	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
Overall Study STARTED	100	100	100
Overall Study COMPLETED	100	100	100
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Simplified Anti-Thrombotic Therapy for FFR

Baseline characteristics by cohort

Measure	Group 1: Upstream Aspirin + Clopidrogel n=100 Participants 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	Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin n=100 Participants 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	Group 3: Upstream Aspirin Plus Bivalirudin n=100 Participants 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 n=300 Participants Total of all reporting groups
Age, Continuous	62 Years STANDARD_DEVIATION 9 • n=5 Participants	65 Years STANDARD_DEVIATION 10 • n=7 Participants	63 Years STANDARD_DEVIATION 8 • n=5 Participants	64 Years STANDARD_DEVIATION 3 • n=4 Participants
Gender Female	38 Participants n=5 Participants	39 Participants n=7 Participants	35 Participants n=5 Participants	112 Participants n=4 Participants
Gender Male	62 Participants n=5 Participants	61 Participants n=7 Participants	65 Participants n=5 Participants	188 Participants n=4 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	100 participants n=5 Participants	300 participants n=4 Participants

PRIMARY outcome

Timeframe: Hospital Stay and after 30 days post PCI

Outcome measures

Measure	Group 1 n=100 Participants 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	Group 2 n=100 Participants 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	Group 3 n=100 Participants 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
Thrombotic Complications	0 Number of Patients	0 Number of Patients	0 Number of Patients

SECONDARY outcome

Timeframe: Hospital Stay and after 30 days post PCI

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

Outcome measures

Measure	Group 1 n=100 Participants 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	Group 2 n=100 Participants 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	Group 3 n=100 Participants 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
TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores	1 Patients	3 Patients	1 Patients

SECONDARY outcome

Timeframe: 48 hours post procedure

Outcome measures

Measure	Group 1 n=100 Participants 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	Group 2 n=100 Participants 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	Group 3 n=100 Participants 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
Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure	0 participants	0 participants	0 participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fernando Boccalandro MD FACC FSCAI

Odessa Heart Institute / Permian Research Foundation

Phone: 432-3373117

Email: Fboccalandro@echd.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place