Trial Outcomes & Findings for Clopidogrel Versus Ticagrelor in Type-2 Diabetes (NCT NCT02742987)

Results Overview

Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Ticagrelor Group Ticagrelor 90 mg twice daily + standard medical therapy Ticagrelor: Ticagrelor 90 mg twice daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions	Clopidogrel Group Clopidogrel 150 mg once daily + standard medical therapy Clopidogrel: Clopidogrel 150 mg once daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ticagrelor Group n=21 Participants Ticagrelor 90 mg twice daily + standard medical therapy Ticagrelor: Ticagrelor 90 mg twice daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions	Clopidogrel Group n=21 Participants Clopidogrel 150 mg once daily + standard medical therapy Clopidogrel: Clopidogrel 150 mg once daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions	Total n=42 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 9.5 • n=5 Participants	67.7 years STANDARD_DEVIATION 8.1 • n=7 Participants	66.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Italy	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion

Outcome measures

Outcome measures
Measure	Ticagrelor Group n=21 Participants Ticagrelor 90 mg twice daily + standard medical therapy Ticagrelor: Ticagrelor 90 mg twice daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions	Clopidogrel Group n=21 Participants Clopidogrel 150 mg once daily + standard medical therapy Clopidogrel: Clopidogrel 150 mg once daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Flow-mediated Dilation of the Brachial Artery	16.6 FMD (%) Standard Deviation 4.8	11.6 FMD (%) Standard Deviation 3.9

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Platelet reactivity assessed with the VerifyNow P2Y12 Assay

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome data not reported

Adverse Events

Ticagrelor Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Clopidogrel Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ticagrelor Group n=21 participants at risk Ticagrelor 90 mg twice daily + standard medical therapy Ticagrelor: Ticagrelor 90 mg twice daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions	Clopidogrel Group n=21 participants at risk Clopidogrel 150 mg once daily + standard medical therapy Clopidogrel: Clopidogrel 150 mg once daily Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 1/21 • Number of events 1 • 30 days	0.00% 0/21 • 30 days

Additional Information

Dr. Fabio Mangiacapra

Campus Bio-Medico University

Phone: 003906225411612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place