Trial Outcomes & Findings for The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study. (NCT NCT04342819)

Last Updated: 2024-09-03

Results Overview

P2Y12 Reaction Units post-Empagliflozin. Citrated blood samples are processed by CRAs and study investigators. The platelet function assay to be utilized is the VerifyNow P2Y12 (VN-P2Y12) assay (Accriva, San Diego, California). In brief, the VN-P2Y12 assay is a rapid whole blood point-of-care device that reports results as P2Y12 reaction units (PRU) and percent inhibition of platelet aggregation (%IPA). Assays will be performed as per the instructions of the manufacturer previously described.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

25 participants

Primary outcome timeframe

14 days

Results posted on

2024-09-03

Participant Flow

All participants provided written informed consent to participate in this prospective, open-label study that aimed to assess the effect of empagliflozin 25 mg once daily for 10 days. Patients were screened and enrolled between January 2020 and August 2020 at the cardiology outpatient clinic at our institution (Eric Williams Medical Sciences Complex, Trinidad and Tobago).

No enrolled patients were excluded from the study before assignment to empagliflozin.

Participant milestones

Participant milestones
Measure	SGLT2i Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	SGLT2i Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor
Overall Study Declined	4
Overall Study Not meeeting selection criteria	1

Baseline Characteristics

The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SGLT2i n=20 Participants Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor
Age, Continuous	64.2 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Trinidad and Tobago	100 participants n=5 Participants
P2Y12 Reaction Units (PRU)	187.35 P2Y12 Reaction Units (PRU) STANDARD_DEVIATION 1 • n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	SGLT2i n=20 Participants Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor
P2Y12 Reaction Units	187.35 P2Y12 Reaction Units Interval 155.38 to 219.32

Adverse Events

SGLT2i

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

Naveen Seecheran, Senior Lecturer

The University of the West Indies

Phone: 18687537686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place