A Phase 4 interventional study of Ticagrelor and Clopidogrel in Coronary Artery Disease and Diabetes Mellitus, sponsored by Campus Bio-Medico University. Completed. Per ClinicalTrials.gov, last updated 2017-08-17.
Sponsored by Campus Bio-Medico University · Phase 4, Interventional, and Treatment
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).
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 42 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ticagrelor 90 mg twice daily + standard medical therapy
Drug: Ticagrelor · Drug: Standard medical therapy
Clopidogrel 150 mg once daily + standard medical therapy
Drug: Clopidogrel · Drug: Standard medical therapy
Ticagrelor 90 mg twice daily
Clopidogrel 150 mg once daily
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Flow-mediated Dilation of the Brachial Artery
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
Time frame: 4 weeks
Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%
Time frame: 4 weeks
Endothelium-independent Dilation of the Brachial Artery
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin
Time frame: 4 weeks
Platelet Reactivity
Platelet reactivity assessed with the VerifyNow P2Y12 Assay
Time frame: 4 weeks
Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units
Time frame: 4 weeks
| Milestone | Ticagrelor Group | Clopidogrel Group |
|---|---|---|
| Started | 21 | 21 |
| Completed | 21 | 21 |
| Not completed | 0 | 0 |
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
| FMD (%) | Ticagrelor Group | Clopidogrel Group |
|---|---|---|
| Flow-mediated Dilation of the Brachial Artery | 16.6 ± 4.8 | 11.6 ± 3.9 |
Results for this outcome have not been posted.
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin
Results for this outcome have not been posted.
Platelet reactivity assessed with the VerifyNow P2Y12 Assay
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ticagrelor Group | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Clopidogrel Group | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Event | Ticagrelor Group | Clopidogrel Group |
|---|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/21 | 0/21 |
| Age, Continuous(years) | Ticagrelor Group | Clopidogrel Group | Total |
|---|---|---|---|
| Mean | 65.9 ± 9.5 | 67.7 ± 8.1 | 66.8 ± 8.8 |
| Sex: Female, Male(Participants) | Ticagrelor Group | Clopidogrel Group | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 19 | 18 | 37 |
| Region of Enrollment(participants) | Ticagrelor Group | Clopidogrel Group | Total |
|---|---|---|---|
| Italy | 21 | 21 | 42 |
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Campus Bio-Medico University