Phase 4 N=42 Randomized Treatment

Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Coronary Artery Disease · Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02742987 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Flow-mediated Dilation of the Brachial Artery — 16.6; 11.6 FMD (%)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ticagrelor (Drug); Clopidogrel (Drug); Standard medical therapy (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Campus Bio-Medico University
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow-mediated Dilation of the Brachial Artery	16.6; 11.6	—
SECONDARY Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%	—	—
SECONDARY Endothelium-independent Dilation of the Brachial Artery	—	—
SECONDARY Platelet Reactivity	—	—
SECONDARY Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units	—	—

Summary

CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with percutaneous coronary intervention (PCI).

Eligibility Criteria

Inclusion Criteria

type 2 diabetes mellitus
stable coronary disease
coronary revascularization with PCI at least 1 month prior to recruitment

Exclusion Criteria

acute coronary syndrome
platelet count <70x109/l
active bleeding or bleeding diathesis
history of intracranial bleeding
gastrointestinal bleeding <6 months
cerebrovascular accident <3 months
history of malignancy
concomitant need for oral anticoagulant therapy
severe liver disease or chronic renal failure (glomerular filtration rate <30 ml/min /1.73m2)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02742987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.