Coronary Artery DiseasePhase 4NCT02742987
Clopidogrel Versus Ticagrelor in Type-2 Diabetes
A Phase 4 study testing Ticagrelor, Clopidogrel and Standard medical therapy in people with Coronary Artery Disease and Diabetes Mellitus, run by Campus Bio-Medico University.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Ticagrelor, Clopidogrel and Standard medical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- stable coronary disease
- coronary revascularization with PCI at least 1 month prior to recruitment
Who cannot join
- acute coronary syndrome
- platelet count <70x109/l
- active bleeding or bleeding diathesis
- history of intracranial bleeding
- gastrointestinal bleeding <6 months
- cerebrovascular accident <3 months
Show all 9Show fewer
- history of malignancy
- concomitant need for oral anticoagulant therapy
- severe liver disease or chronic renal failure (glomerular filtration rate <30 ml/min /1.73m2)
About this study
Official title: CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study
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).
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Ticagrelor, Clopidogrel, Standard medical therapy
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Ticagrelor 90 mg twice daily
ClopidogrelDrug
Clopidogrel 150 mg once daily
Standard medical therapyDrug
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor group | Experimental | Ticagrelor 90 mg twice daily + standard medical therapy Receives: Drug: Ticagrelor; Drug: Standard medical therapy |
| Clopidogrel group | Experimental | Clopidogrel 150 mg once daily + standard medical therapy Receives: Drug: Clopidogrel; Drug: Standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated Dilation of the Brachial Artery
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
Measured: 4 weeks
Secondary outcomes (4)
Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%
Measured: 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
Measured: 4 weeks
Platelet Reactivity
Platelet reactivity assessed with the VerifyNow P2Y12 Assay
Measured: 4 weeks
Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germano Di Sciascio, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742987
- Sponsor's protocol ID
- CLOTILDIA
- Status last verified
- Jul 2017
- First submitted
- 24 Mar 2016
- Last updated
- 17 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study
- ClinicalTrials.gov ID
- NCT02742987
- Acronym / sponsor ID
- CLOTILDIA
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor group | Experimental | Drug: Ticagrelor, Drug: Standard medical therapyTicagrelor 90 mg twice daily + standard medical therapy |
| Clopidogrel group | Experimental | Drug: Clopidogrel, Drug: Standard medical therapyClopidogrel 150 mg once daily + standard medical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes mellitus
- stable coronary disease
- coronary revascularization with PCI at least 1 month prior to recruitment
Key exclusion criteria (9 listed)
- acute coronary syndrome
- platelet count <70x109/l
- active bleeding or bleeding diathesis
- history of intracranial bleeding
- gastrointestinal bleeding <6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorTicagrelor 90 mg twice daily | Drug | Ticagrelor group |
| ClopidogrelClopidogrel 150 mg once daily | Drug | Clopidogrel group |
| Standard medical therapyStandard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions | Drug | Clopidogrel group, Ticagrelor group |
Primary outcome
Flow-mediated Dilation of the Brachial Artery
Time frame: 4 weeks
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
4 secondary outcomes
Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%
Time frame: 4 weeks
Endothelium-independent Dilation of the Brachial Artery
Time frame: 4 weeks
Platelet Reactivity
Time frame: 4 weeks
Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor, Clopidogrel and Standard medical therapy in people with Coronary Artery Disease and Diabetes Mellitus, run by Campus Bio-Medico University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated Dilation of the Brachial Artery (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.