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STEMIPhase 2PITRINCT03102723

Platelet Inhibition to Target Reperfusion Injury

A Phase 2 study testing Cangrelor in people with STEMI, run by National Heart Centre Singapore at 5 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There remains a clinical need to improve health outcomes in patients with ischemic heart disease (IHD) the leading cause of death and disability in Singapore and worldwide. One neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation myocardial infarction (STEMI) patients treated by… Read more about this study

Who is it for?
Ages 21 to 79 years
Conditions the study is for
STEMI
What is being tested?
Cangrelor
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
5 sitesSingapore
Study dates
1 Oct 2017to Dec 2022
Phase
Phase 2
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 21 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria Subjects must meet all of the inclusion criteria to participate in this study.

  1. Age ≥21 and <80 years of age
  2. STEMI as defined by:
  • ≥2 mm ST-segment elevation in 2 or more anterior leads (V1-V4)
  • ≥1 mV ST-segment elevation in in 2 or more limb leads (II, III and aVF, I, aVL).
  • ST elevation in II, II, aVF less than 1 mm with ST depression in aVL
  • Posterior infarction ST depression ≥ 1 mm over either V1, V2, or V3 and ST elevation ≥ 1 mm in either V7, V8 or V9
  1. ≤6 hours onset of most severe chest pain to time of admission in the Emergency Medicine Department

Exclusion Criteria All subjects meeting any of the exclusion criteria at baseline will be excluded from participation.

  1. History of previous MI, CVA, TIA or prior CABG surgery
  2. Known contraindications to cardiac MRI (CMR) such as MRI contraindicated implanted devices, significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (estimated glomerular filtration rate [eGFR] ≤40 mL/min/1.73 m2)
  3. Patients with prior therapy before admission within 7 days of anticoagulant (warfarin, phenindione, dabigatran, apixaban and rivaroxaban), glycoprotein 2B3A inhibitor, P2Y12 inhibitor (ticagrelor, prasugrel, clopidogrel, cangrelor) or thrombolytic therapy
  4. Significant co-morbidities:
  • Patients with severe hepatic failure (INR>2)
  • Cardiac arrest before randomisation
  • Cardiogenic shock
  • Poor premorbid status (bed bound / wheelchair bound)
  • Collapse / comatose / semi-conscious states
  1. Contraindications to Heparinisation or Anti-Platelet Therapy:
  • History of Heparin-Induced Thrombocytopenia (HIT)
  • Increased bleeding risk (GI bleeding, traumatic head injury)
  1. Pregnancy
  2. Contrast allergy
  3. Patients on strong CYP3A inhibitors or inducers (such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, rifampin, dexamethasone, phenytoin, carbamazepine, and phenobarbital)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Singapore5 sites

  • National University Hospital (NUH)

    Singapore, 119228

  • Tan Tock Seng Hospital (TTSH)

    Singapore, 308433

  • Khoo Teck Puat Hospital

    Singapore, 768828

  • Changi General Hospital

    Singapore, S529889

  • SengKang General Hospital

    Singapore, S544886

Other trials in Singapore

About this study

Official title: Platelet Inhibition to Target Reperfusion Injury: The PITRI Trial

There remains a clinical need to improve health outcomes in patients with ischemic heart disease (IHD) the leading cause of death and disability in Singapore and worldwide. One neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been demonstrated in experimental animal studies to reduce MI size when administered prior to reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.

Read the detailed description

The PITRI proof-of-concept clinical trial will randomise 210 STEMI patients to receive either Cangrelor (single intravenous bolus followed by a 120-minute infusion) or matching normal/saline placebo, initiated prior to PPCI on top of conventional oral dual antiplatelet therapy (Aspirin + Ticagrelor).

The primary endpoint will be acute MI size by cardiac MRI at day 2-7. Secondary endpoints will include incidence and extent of MVO by cardiac MRI; and chronic MI size, left ventricular size and ejection fraction by cardiac MRI at 6 months.

Conditions
STEMI
Being tested
Cangrelor
Keywords
STEMI, primary percutaneous coronary intervention (PPCI), cangrelor, reperfusion
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.

  • CangrelorDrug

    Also called Kengreal

    1. Cangrelor treatment: IV Cangrelor as a single IV bolus (30 μg/kg) followed by an infusion (4 μg/kg/min) of at least 120 minutes duration or until PPCI procedure has ended (whichever is longer) - this will be initiated prior to PPCI. This dosing regimen is identical to that used in the CHAMPION trials. Or
    2. Placebo control: IV normal saline as a single IV bolus followed by an infusion of at least 120 minutes duration or until PPCI procedure has ended (whichever is longer) - this will be initiated prior to PPCI.
Study groups in NCT03102723
Study groupRoleWhat they receive
CangrelorExperimentalCangrelor (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
Receives: Drug: Cangrelor
PlaceboPlacebo comparatorMatching normal saline placebo (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
Receives: Drug: Cangrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial infarct size by CMR at Day 2 to 7

    This will be measured by CMR (mass of late gadolinium enhancement expressed as a percentage of the LV mass).

    Measured: 2-7 days

Secondary outcomes (12)

  1. Microvascular obstruction to calculate myocardial interstitial volume

    This will be assessed by CMR performed at 2-7 days post-PPCI

    Measured: 2-7 days

  2. Myocardial salvage index

    This will be assessed by cardiac magnetic resonance (CMR) performed at 2-7 days post-PPCI by measuring MI size and the area at risk

    Measured: 2-7 days

  3. Angiographic markers of successful reperfusion

    ST-segment resolution 90 min post-PPCI, TIMI flow and frame-count post-PPCI, and TIMI blush grade

    Measured: 2 to 3 hours

  4. Myocardial infarct size by CMR at 6 months

    This will be measured by Cardiac MRI 6 months post-PPCI

    Measured: 6 months

  5. Post-MI LV remodeling by measuring LV ejection fraction and indexed LV end systolic and diastolic volumes and mass

    This will be assessed by CMR by measuring LV ejection fraction and indexed LV end systolic and diastolic volumes and mass.

    Measured: 6 months

  6. Platelet function testing

    Serial platelet function testing will be performed with VerifyNow in a subset of 70 patients.

    Measured: 2 hours

  7. MACCE at 30 days, at 6 months, at 12 months, at 24 months, at 5 years and at 10 years

    This will include all-cause death, hospitalisation for heart failure (HHF), stent thrombosis, ischemia-induced coronary revascularisation, re-infarction, and stroke. This data will be collected by telephone and reviewing medical notes at 30 days and at the time of the outpatient 6 month cardiac MR scan.

    Measured: 6 months

  8. Incidence of definite stent thrombosis at 48 hours

    This will be defined according to the criteria of the Academic Research Consortium, which was assessed, with group assignments concealed, at an angiographic core laboratory (Cardiovascular Research Foundation).

    Measured: 48 hours

  9. Quality of life questionnaire

    The EuroQol EQ-5D Health-Related Quality of Life (EUROQOL) questionnaire (www.euroqol.org) will be used to assess patient quality of life post-CABG with or without valve surgery, at baseline (1 day post-PPCI), 30 days (by telephone), and 6 months (at time of outpatient CMR scan).

    Measured: 6 months

  10. 6-Minute Walk Test (6MWT)

    Functional capacity of patients will be measured using the 6-Minute Walk Test

    Measured: 6 months

  11. Subjective questionnaire

    Subjective questionnaire relating to symptoms post angioplasty and physical activities will be assess at 30±7 days (by telephone), and at 6±1 months (at time of the outpatient CMR scan).

    Measured: 6 months

  12. ALDH2 substudy

    A saliva sample will be collected from a sub-group of subjects for determination of their ALDH2 genotype.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2017
  2. Study start1 Oct 2017
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03102723
Sponsor's protocol ID
PITRI-01
Acronym
PITRI
Status last verified
Apr 2022
First submitted
5 Jan 2017
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bulluck H, Chong JH, Bryant J, Annathurai A, Chai P, Chan M, Chawla A, Chin CY, Chung YC, Gao F, Ho HH, Ho AFW, Hoe J, Imran SS, Lee CH, Lim B, Lim ST, Lim SH, Liew BW, Zhan Yun PL, Ong MEH, Paradies V, Pung XM, Tay JCK, Teo L, Ting BP, Wong A, Wong E, Watson T, Chan MY, Keong YK, Tan JWC, Hausenloy DJ; PITRI Investigators. Effect of Cangrelor on Infarct Size in ST-Segment-Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: A Randomized Controlled Trial (The PITRI Trial). Circulation. 2024 Jul 9;150(2):91-101. doi: 10.1161/CIRCULATIONAHA.124.068938. Epub 2024 May 14.

    PubMed 38742915

  • Bulluck H, Chan MHH, Bryant JA, Chai P, Chawla A, Chua TS, Chung YC, Fei G, Ho HH, Ho AFW, Hoe AJ, Imran SS, Lee CH, Lim SH, Liew BW, Yun PLZ, Hock MOE, Paradies V, Roe MT, Teo L, Wong AS, Wong E, Wong PE, Watson T, Chan MY, Tan JW, Hausenloy DJ. Platelet inhibition to target reperfusion injury trial: Rationale and study design. Clin Cardiol. 2019 Jan;42(1):5-12. doi: 10.1002/clc.23110. Epub 2018 Dec 17.

    PubMed 30421441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cangrelor in people with STEMI, run by National Heart Centre Singapore at 5 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Singapore. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Myocardial infarct size by CMR at Day 2 to 7 (time frame: 2-7 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 NCT03102723, which also lists 2 linked publications.

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 26 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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