Trial Outcomes & Findings for Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion (NCT NCT01919723)

Results Overview

Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Baseline and 2 hours

Results posted on

2017-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Ticagrelor and Eptifibatide Bolus Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
Overall Study STARTED	35	35
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ticagrelor and Eptifibatide Bolus Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
Overall Study Blood Samples Hemolyzed	2	2

Baseline Characteristics

Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ticagrelor and Eptifibatide Bolus n=35 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) Ticagrelor: Ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion n=35 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) Ticagrelor: Ticagrelor loading dose Eptifibatide: i.v. infusion	Total n=70 Participants Total of all reporting groups
Age, Customized >=19 years	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Gender Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Gender Male	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 hours

Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.

Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.

Outcome measures

Outcome measures
Measure	Ticagrelor and Eptifibatide Bolus n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
Change in Percent Inhibition of Platelet Aggregation (%IPA)	99.59 percentage of IPA Standard Deviation 0.43	99.88 percentage of IPA Standard Deviation 1.0

SECONDARY outcome

Timeframe: Comparing baseline and follow-up (2 hours)

Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.

Percentage of participants with HPR. HPR is defined as platelet aggregation \>59% in response to 20 µM ADP.

Outcome measures

Outcome measures
Measure	Ticagrelor and Eptifibatide Bolus n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
High On-treatment Platelet Reactivity (HPR) Baseline	89 percentage of participants	79 percentage of participants
High On-treatment Platelet Reactivity (HPR) 2 h	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: up to 24 hours

Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.

Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.

Outcome measures

Outcome measures
Measure	Ticagrelor and Eptifibatide Bolus n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
Bleeding Complications	0 Number of subjects	1 Number of subjects

SECONDARY outcome

Timeframe: Up to 24 hours

Population: 2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.

Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values \>5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values \>20% after PCI if the baseline value was elevated.

Outcome measures

Outcome measures
Measure	Ticagrelor and Eptifibatide Bolus n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion n=33 Participants Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
Periprocedural Myocardial Infarction (PMI)	9 Number of subjects	7 Number of subjects

Adverse Events

Ticagrelor and Eptifibatide Bolus

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Ticagrelor & Eptifibatide Bolus+Infusion

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ticagrelor and Eptifibatide Bolus n=33 participants at risk Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion	Ticagrelor & Eptifibatide Bolus+Infusion n=33 participants at risk Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours) ticagrelor: ticagrelor loading dose Eptifibatide: i.v. infusion
Cardiac disorders Death	0.00% 0/33	3.0% 1/33 • Number of events 1
Cardiac disorders NSTEMI	3.0% 1/33 • Number of events 1	0.00% 0/33
Gastrointestinal disorders Gastrointestinal Bleeding	0.00% 0/33	3.0% 1/33 • Number of events 1
Blood and lymphatic system disorders Target Lesion Revascularization (TLR)	0.00% 0/33	3.0% 1/33 • Number of events 1
Cardiac disorders Periprocedural Myenecrosis	27.3% 9/33 • Number of events 9	21.2% 7/33 • Number of events 7

Other adverse events

Adverse event data not reported

Additional Information

Mehak Goel ,PhD

University of Alabama at Birmingham

Phone: 205-975-4021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place