ST-Elevation Myocardial InfarctionPhase 3RESET 2DNCT01531114
PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
A Phase 3 study testing ticagrelor and prasugrel in people with ST-Elevation Myocardial Infarction, run by Gennaro Sardella at 1 site in Italy.
Trial summary
Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- ticagrelor and prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jul 2015
- Phase
- Phase 3
- 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
- Diabetic patients
- acute coronary syndrome
- patients underwent to primary PCI
- naïve for platelet P2Y12 receptor inhibition therapy
Who cannot join
- history of bleeding diathesis
- chronic oral anticoagulation treatment
- contraindications to antiplatelet therapy
- PCI or coronary artery bypass grafting (CABG) < 3 months
- hemodynamic instability
- platelet count < 100,000/μl
Show all 13Show fewer
- hematocrit < 30%
- creatinine clearance < 25 ml/min
- Patients with a history of stroke
- contraindication for prasugrel administration
- patients weighing < 60 kg
- patients treated with morphine
- > 75 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus
Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- ticagrelor, prasugrel
- Keywords
- Diabetes mellitus, antiplatelet effect, prasugrel, ticagrelor, STEMI, Insulin
- Medical subject headings
- ST Elevation Myocardial Infarction, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Patients will be randomized to this arm to receive loading dose of ticagrelor
prasugrelDrug
Patients will be randomized to this arm to receive loading dose of prasugrel
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel loading dose | Active comparator | Patients will be randomized to this arm to receive loading dose of prasugrel Receives: Drug: ticagrelor; Drug: prasugrel |
| ticagrelor loading dose | No intervention | Patients will be randomized to this arm to receive loading dose of ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration.
Measured: 1 and 2 hours
Secondary outcomes (1)
PR level measured at 6 and 12 hours post study drugs administration.
Measured: in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-Elevation Myocardial InfarctionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gennaro Sardella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gennaro Sardella, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531114
- Sponsor's protocol ID
- RESET 2D Trial
- Acronym
- RESET 2D
- Status last verified
- Jun 2017
- First submitted
- 7 Feb 2012
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01531114
- Acronym / sponsor ID
- RESET 2D / RESET 2D Trial
- Conditions
- ST-Elevation Myocardial Infarction
- Keywords
- Diabetes mellitus, antiplatelet effect, prasugrel, ticagrelor, STEMI, Insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gennaro SardellaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Feb 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.
Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel loading dose | Active comparator | Drug: ticagrelor, Drug: prasugrelPatients will be randomized to this arm to receive loading dose of prasugrel |
| ticagrelor loading dose | No intervention | –Patients will be randomized to this arm to receive loading dose of 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)
- Diabetic patients
- acute coronary syndrome
- patients underwent to primary PCI
- naïve for platelet P2Y12 receptor inhibition therapy
Key exclusion criteria (13 listed)
- history of bleeding diathesis
- chronic oral anticoagulation treatment
- contraindications to antiplatelet therapy
- PCI or coronary artery bypass grafting (CABG) < 3 months
- hemodynamic instability
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 |
|---|---|---|
| ticagrelorPatients will be randomized to this arm to receive loading dose of ticagrelor | Drug | Prasugrel loading dose |
| prasugrelPatients will be randomized to this arm to receive loading dose of prasugrel | Drug | Prasugrel loading dose |
Primary outcome
the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration.
Time frame: 1 and 2 hours
1 secondary outcome
PR level measured at 6 and 12 hours post study drugs administration.
Time frame: in hospital
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 28 Jun 2017.
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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 3 study testing ticagrelor and prasugrel in people with ST-Elevation Myocardial Infarction, run by Gennaro Sardella at 1 site in Italy.
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 13 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 28 Jun 2017. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration. (time frame: 1 and 2 hours). 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 28 Jun 2017.