Coronary Artery DiseasePhase 4NCT01642940
Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study
A Phase 4 study testing Prasugrel and Ticagrelor in people with Coronary Artery Disease and Acute Coronary Syndrome, run by University of Patras at 1 site in Greece.
Trial summary
This is a prospective, randomized, single-center, single blind, investigator initiated, two period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS), treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected to percutaneous coronary intervention (PCI)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Prasugrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2012to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- Diabetic patients treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month
- Patients with acute coronary syndrome subjected to PCI with a baseline PR evaluation 24 hours post PCI while on clopidogrel
- Informed consent obtained in writing
Who cannot join
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
- Cardiogenic shock
- Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
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- Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 30 days after randomization
- Requirement for oral anticoagulant prior to the Day 30 visit
- Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
- Known hypersensitivity to prasugrel or ticagrelor
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm thienopyridine therapy.
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (< 100.000/μL) at randomization
- Anaemia (Hct < 30%) at randomization
- Polycytaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitors administration
- Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
- Recent (< 6 weeks) major surgery or trauma, including GABG.
- Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
- Increased risk of bradycardiac events.
- Dialysis required.
- Age ≥ 75 years
- Weight < 60 Kg
- Severe hepatic impairment
- Severe uncontrolled chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiology Department Patras University Hospital
Pátrai, Achaia, 26500
About this study
This is a prospective, randomized, single-center, single blind, investigator initiated, two period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS), treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the alternate therapy for an additional 15 days without an intervening washout period.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Prasugrel, Ticagrelor
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Prasugrel 10mg/day
TicagrelorDrug
Ticagrelor 90mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Active comparator | Not described Receives: Drug: Prasugrel |
| Ticagrelor | Experimental | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
The primary outcome will be assessed 15 days after the onset of each study drug by the VerifyNow (Accumetrics)assay in platelet reactivity units (PRU)
Measured: 15 days
Secondary outcomes (1)
Hyporesponsiveness rate (PRU≥230) at the end of the 2 treatment periods
Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Alexopoulos, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642940
- Sponsor's protocol ID
- PATRASCARDIOLOGY-11
- Status last verified
- Jan 2013
- First submitted
- 12 Jul 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexopoulos D, Xanthopoulou I, Mavronasiou E, Stavrou K, Siapika A, Tsoni E, Davlouros P. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with diabetes. Diabetes Care. 2013 Aug;36(8):2211-6. doi: 10.2337/dc12-2510. Epub 2013 Mar 14.
PubMed 23491524
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study
- ClinicalTrials.gov ID
- NCT01642940
- Acronym / sponsor ID
- PATRASCARDIOLOGY-11
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, single-center, single blind, investigator initiated, two period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS), treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the alternate therapy for an additional 15 days without an intervening washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Active comparator | Drug: Prasugrel |
| Ticagrelor | Experimental | Drug: Ticagrelor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years
- Diabetic patients treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month
- Patients with acute coronary syndrome subjected to PCI with a baseline PR evaluation 24 hours post PCI while on clopidogrel
- Informed consent obtained in writing
Key exclusion criteria (27 listed)
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
- Cardiogenic shock
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 |
|---|---|---|
| PrasugrelPrasugrel 10mg/day | Drug | Prasugrel |
| TicagrelorTicagrelor 90mg twice a day | Drug | Ticagrelor |
Primary outcome
Platelet reactivity
Time frame: 15 days
The primary outcome will be assessed 15 days after the onset of each study drug by the VerifyNow (Accumetrics)assay in platelet reactivity units (PRU)
1 secondary outcome
Hyporesponsiveness rate (PRU≥230) at the end of the 2 treatment periods
Time frame: Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Derived from this study: PubMed 23491524Alexopoulos D, Xanthopoulou I, Mavronasiou E, Stavrou K, Siapika A, Tsoni E, Davlouros P. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with diabetes. Diabetes Care. 2013 Aug;36(8):2211-6. doi: 10.2337/dc12-2510. Epub 2013 Mar 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel and Ticagrelor in people with Coronary Artery Disease and Acute Coronary Syndrome, run by University of Patras at 1 site in Greece.
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 4 inclusion and 27 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Platelet reactivity (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642940, which also lists 1 linked publication.
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 23 Jan 2013.