ST Elevation Myocardial InfarctionCOMPARENCT03435133
Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI
A study testing Prasugrel and Ticagrelor in people with ST Elevation Myocardial Infarction, run by AORTICA Group at 1 site in Spain.
Trial summary
The investigators propose to perform a randomized clinical trial comparing prasugrel vs. ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. 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?
- Prasugrel and Ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 23 Nov 2015to 31 Dec 2018
- Phase
- Interventional
- 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 years or older and equal or less than 75 years
- symptom onset within 12 hours before random assignment
- chest pain lasting more than 30 minutes
- ST-segment elevation of at least 0.1 mV in at least 2 limb leads, ST-segment elevation of at least 0.2 mV in 2 or more contiguous precordial leads, or left bundle-branch block or paced rhythm
- time from symptoms onset to randomization less than 6 hours
- no severe heart failure (Killip class <3)
- informed, written consent
Who cannot join
- history of myocardial infarction with Q wave
- history of surgical or percutaneous coronary revascularization
- cardiogenic shock, defined as a systolic blood pressure <90 mm Hg with no response to fluid administration or <100 mm Hg in patients with supportive treatment and no bradycardia
- history of stroke
- history of bronchial asthma
- symtomatic sinusal bradicardia or advance AV block
Show all 9Show fewer
- history of hypersensitivity to aspirin, prasugrel or ticagrelor or contraindication to the doses established in the study
- patients pretreated with 600 mg of clopidogrel or more
- contraindication for the use of gadolinium during the magenitc resonance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients
The investigators propose to perform a randomized clinical trial comparing prasugrel vs. ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The principal objective of the study would be analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance at 6 months
Read the detailed description
Dual antiplatelet therapy consisting of aspirin and one of the P2Y12 receptor inhibitors is the mainstay of treatment for patients with ST elevation acute myocardial infarction undergoing primary percutaneous coronary intervention. Prasugrel or ticagrelor have actually shown to be superior to clopidogrel improving the prognosis of these patients. However, the industrial interest has avoided any direct comparison between these two antiplatelets. Comparison is of great interest considering that only ticagrelor has shown to significantly reduce mortality. As ticagrelor may exert off-target effects through adenosine-related mechanisms, the investigators aimed to investigate whether ticagrelor reduces myocardial injury to a greater extent than prasugrel in patients with revascularized STEMI.
Patients with acute STEMI undergoing primary percutaneous coronary revascularization within 6 hours of chest pain, will be randomized to (1) prasugrel (a 60 mg oral loading and a 10-mg dailiy maintenance dose) or to (2) ticagrelor (a 180 mg loading dose and a 90 mg twice daily maintenance dose). The predefined primary end point is infarct sieze on magnetic resonance imaging at the end of the study (6 months). Magnetic resonance will be performed at day 1, day 7 and moth 6. Platelet reactivity, biomarkers and clinical outcomes will also be assesed.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Prasugrel, Ticagrelor
- Keywords
- Primary angioplasty, Prasugrel, Ticagrelor, STEMI, cardiac magnetic resonance, infarct size, infarct injury
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
60 mg oral bolus plus oral 10 mg once daily
TicagrelorDrug
180 mg oral bolus plus oral 90 mg every 12 hours daily
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Active comparator | Not described Receives: Drug: Prasugrel |
| Ticagrelor | Active comparator | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Measured: 6 months
Secondary outcomes (4)
Infarct size
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Measured: up to two weeks
Myocardial salvage index
Cardiac magnetic resonance imaging-assessed myocardial salvage index
Measured: up to two weeks
Microvascular obstruction
Cardiac magnetic resonance imaging-assessed microvascular obstruction
Measured: up to two weeks
MACE
The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start23 Nov 2015
- Primary completion30 Oct 2018
- Study completion31 Dec 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- AORTICA Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro L Sanchez, AORTICA Group
- Investigators
- Pedro L Sanchez, MD, PhD, Principal investigator, Hospital Universitario Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435133
- Sponsor's protocol ID
- CARDIO2015.1
- Acronym
- COMPARE
- Status last verified
- Jun 2019
- First submitted
- 5 Feb 2018
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT03435133
- Acronym / sponsor ID
- COMPARE / CARDIO2015.1
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- Primary angioplasty, Prasugrel, Ticagrelor, STEMI, cardiac magnetic resonance, infarct size, infarct injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AORTICA GroupUniversity, hospital or other
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Feb 2018 (actual)
- 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.
The investigators propose to perform a randomized clinical trial comparing prasugrel vs. ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The principal objective of the study would be analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance at 6 months
Detailed description
Dual antiplatelet therapy consisting of aspirin and one of the P2Y12 receptor inhibitors is the mainstay of treatment for patients with ST elevation acute myocardial infarction undergoing primary percutaneous coronary intervention. Prasugrel or ticagrelor have actually shown to be superior to clopidogrel improving the prognosis of these patients. However, the industrial interest has avoided any direct comparison between these two antiplatelets. Comparison is of great interest considering that only ticagrelor has shown to significantly reduce mortality. As ticagrelor may exert off-target effects through adenosine-related mechanisms, the investigators aimed to investigate whether ticagrelor reduces myocardial injury to a greater extent than prasugrel in patients with revascularized STEMI.
Patients with acute STEMI undergoing primary percutaneous coronary revascularization within 6 hours of chest pain, will be randomized to (1) prasugrel (a 60 mg oral loading and a 10-mg dailiy maintenance dose) or to (2) ticagrelor (a 180 mg loading dose and a 90 mg twice daily maintenance dose). The predefined primary end point is infarct sieze on magnetic resonance imaging at the end of the study (6 months). Magnetic resonance will be performed at day 1, day 7 and moth 6. Platelet reactivity, biomarkers and clinical outcomes will also be assesed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Active comparator | Drug: Prasugrel |
| Ticagrelor | Active comparator | Drug: Ticagrelor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 years or older and equal or less than 75 years
- symptom onset within 12 hours before random assignment
- chest pain lasting more than 30 minutes
- ST-segment elevation of at least 0.1 mV in at least 2 limb leads, ST-segment elevation of at least 0.2 mV in 2 or more contiguous precordial leads, or left bundle-branch block or paced rhythm
- time from symptoms onset to randomization less than 6 hours
Key exclusion criteria (9 listed)
- history of myocardial infarction with Q wave
- history of surgical or percutaneous coronary revascularization
- cardiogenic shock, defined as a systolic blood pressure <90 mm Hg with no response to fluid administration or <100 mm Hg in patients with supportive treatment and no bradycardia
- history of stroke
- history of bronchial asthma
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 |
|---|---|---|
| Prasugrel60 mg oral bolus plus oral 10 mg once daily | Drug | Prasugrel |
| Ticagrelor180 mg oral bolus plus oral 90 mg every 12 hours daily | Drug | Ticagrelor |
Primary outcome
Infarct size
Time frame: 6 months
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
4 secondary outcomes
Infarct size
Time frame: up to two weeks
Myocardial salvage index
Time frame: up to two weeks
Microvascular obstruction
Time frame: up to two weeks
MACE
Time frame: 6 months
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 10 Jun 2019.
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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.
Pedro L Sanchez, MD, PhD principal investigator
Hospital Universitario Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prasugrel and Ticagrelor in people with ST Elevation Myocardial Infarction, run by AORTICA Group at 1 site in Spain.
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 7 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 10 Jun 2019. 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 Spain. 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.
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?
Infarct size (time frame: 6 months). 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 10 Jun 2019.