Trial Outcomes & Findings for Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction (NCT NCT02931045)

Results Overview

Concentration of platelet extracellular vesicles/ml measured with flow cytometry

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

6 months following the beginning of antiplatelet therapy

Results posted on

2020-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	Ticagrelor Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)	Clopidogrel Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
Overall Study STARTED	30	30
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ticagrelor n=30 Participants Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)	Clopidogrel n=30 Participants Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=30 Participants	16 Participants n=30 Participants	35 Participants n=60 Participants
Age, Categorical >=65 years	11 Participants n=30 Participants	14 Participants n=30 Participants	25 Participants n=60 Participants
Sex: Female, Male Female	8 Participants n=30 Participants	6 Participants n=30 Participants	14 Participants n=60 Participants
Sex: Female, Male Male	22 Participants n=30 Participants	24 Participants n=30 Participants	46 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Poland	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: 6 months following the beginning of antiplatelet therapy

Concentration of platelet extracellular vesicles/ml measured with flow cytometry

Outcome measures

Outcome measures
Measure	Ticagrelor n=27 Participants Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) 27 patients	Clopidogrel n=28 Participants Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) 28 patients
Concentration of Platelet Extracellular Vesicles/ml	2690000 Platelet Extracellular Vesicles/mL Interval 1460000.0 to 4190000.0	4310000 Platelet Extracellular Vesicles/mL Interval 2050000.0 to 6240000.0

SECONDARY outcome

Timeframe: 6 months

Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry

Outcome measures

Outcome data not reported

Adverse Events

Ticagrelor

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Clopidogrel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ticagrelor n=30 participants at risk Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) 27 patients One major bleeding event from the gynecologic tract	Clopidogrel n=30 participants at risk Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) 28 patients One major bleeding event from a diabetic foot ulcer
Reproductive system and breast disorders One major bleeding event from the gynecologic tract	3.3% 1/30 • Number of events 1 • 6 months	3.3% 1/30 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders One major bleeding event from a diabetic foot ulcer	3.3% 1/30 • Number of events 1 • 6 months	3.3% 1/30 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Aleksandra Gasecka, MD, PhD

1st Chair and Department of Cardiology, Medical University of Warsaw

Phone: +48225991951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place