ClinicalTrials.gg
CompletedNCT03435133COMPAREUpdated Jun 10, 2019

Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI

An interventional study of Prasugrel and Ticagrelor in ST Elevation Myocardial Infarction, sponsored by AORTICA Group. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by AORTICA Group · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Nov 2015, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies testing prasugrel in ST Elevation Myocardial Infarction — none open to participants now, none under way, none of them phase 3. prasugrel · ST Elevation Myocardial Infarction.

Enrollment
9th of 13
61 · median 82
Started
2015
with 1 other
No phase
Only one
of the 13
Registered
12th of 13
by date
Lead sponsor
1 of 13
AORTICA Group

Among the 13 studies testing prasugrel in ST Elevation Myocardial Infarction, this one is the 9th largest by enrollment, is one of 2 that started in 2015, is the only one with no phase, and was the 12th registered.

ST Elevation Myocardial Infarction

850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.

Browse ST Elevation Myocardial Infarction studies →

Open to participants now

None of the 13 studies testing prasugrel in ST Elevation Myocardial Infarction is open now.

About prasugrel

prasugrel: first FDA approval 2009 (EFFIENT), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 13 studies testing prasugrel in ST Elevation Myocardial Infarction as a file.
02

Study 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. 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.

03

Conditions studied

  • ST Elevation Myocardial Infarction

Keywords

  • Primary angioplasty
  • Prasugrel
  • Ticagrelor
  • STEMI
  • cardiac magnetic resonance
  • infarct size
  • infarct injury
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • history of to aspirin, prasugrel or ticagrelor or 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Active comparator
    Prasugrel

    Drug: Prasugrel

  • Active comparator
    Ticagrelor

    Drug: Ticagrelor

Interventions

  • 60 mg oral bolus plus oral 10 mg once daily

  • 180 mg oral bolus plus oral 90 mg every 12 hours daily

06

What researchers measure

Primary outcomes

  1. Infarct size

    Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)

    Time frame: 6 months

Secondary outcomes

  1. Infarct size

    Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)

    Time frame: up to two weeks

  2. Myocardial salvage index

    Cardiac magnetic resonance imaging-assessed myocardial salvage index

    Time frame: up to two weeks

  3. Microvascular obstruction

    Cardiac magnetic resonance imaging-assessed microvascular obstruction

    Time frame: up to two weeks

  4. MACE

    The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization

    Time frame: 6 months

07

Study locations

1 site
  • Pedro Dorado
    Salamanca, 37007, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2015 to primary completion in Oct 2018, 35 months.

Of 134 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's 35 months is close to that.

Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 19 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2018
First posted
Feb 15, 2018
StartActual
Nov 23, 2015
Primary completionActual
Oct 30, 2018
CompletionActual
Dec 31, 2018
Last update
Jun 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03435133
Lead sponsor
AORTICA Group
Responsible party
Pedro L Sanchez (Head of Cardiology, PhD, MD, AORTICA Group) — Principal investigator
First posted
Feb 15, 2018
Start date
Nov 23, 2015
Primary completion
Oct 30, 2018
Completion
Dec 31, 2018
Last update
Jun 10, 2019

Study contacts

Pedro L Sanchez, MD, PhD
principal investigator · Hospital Universitario Salamanca

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Prasugrel · Ticagrelor

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