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ST-Segment Elevation Myocardial InfarctionPhase 2NCT01738100

Ticagrelor and Intracoronary Morphine in Patients Undergoing Primary Percutaneous Coronary Intervention

A Phase 2 study testing Ticagrelor, Clopidogrel and Morphine Sulfate in people with ST-Segment Elevation Myocardial Infarction, run by Hyeon-Cheol Gwon at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint trial. Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Ticagrelor, Clopidogrel and Morphine Sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
Sep 2012to Dec 2016
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion criteria
  • Subject must be at least 20 years of age.
  • Patients undergoing primary PCI for STEMI
  • Diagnosis of STEMI: ST-segment elevation >0.1 millivolt in ≥2 contiguous leads or (presumably) new left bundle branch block
  • Presence of symptoms less than 12 hours
  • Additional inclusion criteria for intracoronary morphine
  • TIMI flow grade 0 or 1 of infarct related arteries
  1. Exclusion Criteria:
  • Known hypersensitivity or contraindication to study medications or contrast
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  • Rescue PCI after thrombolysis or facilitated PCI
  • Cardiogenic shock or cardiopulmonary resuscitation before randomization
  • Known chronic hepatic disease
  • Known renal dysfunction (creatinine level 3.0mg/dL or dependence on dialysis).
  • Decompensated chronic obstructive pulmonary disease or active asthma at inclusion
  • Mechanical ventilation at inclusion
  • Brain injury or intracranial hypertension
  • Acute alcohol intoxication
  • Known ulcerative colitis
  • Active epilepsy
  • Contraindications to undergo MRI imaging include any of the following
  • A cardiac pacemaker or implantable defibrillator; any implanted or magnetically activated device; or any history indicating contraindication to MRI including claustrophobia or allergy to gadolinium
  • Current use of oral anticoagulant
  • An increased risk of bradycardia
  • Sinus node dysfunction, atrioventricular dysfunction, or heart rate <40/min
  • Patients receiving clopidogrel 300 mg or more before randomization
  • One of followings
  • history of intracranial bleeding
  • intracranial tumor, arteriovenous malformation or aneurysm
  • stroke within past 3 months
  • Active bleeding of internal organ or bleeding diathesis
  • Acute aortic dissection

Trial locations and contacts

1 site in 1 country.

Hyeon-Cheol Gwon, MD/PhD contact

82-2-3410-6653

hcgwon62@gmail.com

Joo-Yong Hahn, MD/PhD contact

82-2-3410-6653

jyhahn@skku.edu

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, Gang nam-Gu, Ilwon-Dong, 135-710

    Hyeon-Cheol Gwon, PhD, 82-2-3410-6653, hcgwon@skku.edu

    Joo-Yong Hahn, PhD, 82-2-3410-6653, jy.hahn@samsung.com

    Recruiting

Other trials in South Korea

About this study

Official title: Effects of Ticagrelor and Intracoronary Morphine on Myocardial Salvage in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint trial. Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. After emergent coronary angiography, patients who have thrombolysis in myocardial infarction (TIMI) flow grade <2 in coronary angiogram will be randomized again, to either bolus intracoronary injection of morphine sulfate or saline in a 1:1 ratio. Randomization will be stratified by infarct location (anterior vs. non-anterior), and morphine use for pain control before study enroll (for only intracoronary morphine).

Read the detailed description

1.1. Ticagrelor versus Clopidogrel

  1. In spite of timely and successful reperfusion with primary percutaneous coronary intervention (PCI), the mortality rate still remains high1 and substantial numbers of patients suffer from subsequent left ventricular dysfunction or heart failure after ST-segment elevation myocardial infarction (STEMI).
  2. One of limitations of primary PCI is distal embolization and effective antiplatelet therapy is needed in patients with STEMI.
  3. Clopidogrel is a representative P2Y12 receptor antagonist and has shown consistent efficacy in patients with acute coronary syndromes. However, clopidogrel is a prodrug and has to be converted to an active metabolite to inhibit P2Y12 receptor. Therefore, onset of effect is relatively slow, antiplatelet effect is moderate, and response to clopidogrel shows wide individual variability.
  4. Ticagrelor is a new, direct, reversible P2Y12 receptor antagonist, which has rapid and potent antiplatelet effect. In patients who have an acute coronary syndrome with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, myocardial infarction, or stroke without an increase in the rate of overall major bleeding.
  5. However, there has been no data whether ticagrelor can reduce infarct size compared with clopidogrel in patients undergoing primary PCI.

1.2. Intracoronary morphine administration

  1. Lethal reperfusion injury accounts for up to 50% of the final size of a myocardial infarct.5,6 Therefore, adjunctive therapy that is effective in preventing lethal reperfusion injury is needed to potentiate the benefits of primary PCI.
  2. During the past few decades, a large number of animal studies demonstrated that commonly used opioids could provide cardioprotection against ischemia-reperfusion injury. Opioid-induced preconditioning or postconditioning mimics ischemic preconditioning or ischemic postconditioning.
  3. Recent small clinical trial demonstrated the cardioprotective effect of remote ischemic preconditioning and morphine during primary PCI. But this study was small and did not demonstrate the separate effect of morphine-induced cardioprotection.
  4. Study Objective
  5. To investigate the effects of ticagrelor on myocardial infarct size in patients with STEMI undergoing primary PCI compared with clopidogrel
  6. To investigate the effects of morphine-induced cardioprotection during primary PCI in patients with STEMI
Being tested
Ticagrelor, Clopidogrel, Morphine Sulfate, Saline
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.

  • TicagrelorDrug

    Also called Brilinta

  • ClopidogrelDrug

    Also called Plavix

  • Morphine SulfateDrug

    Also called Morphine

  • SalineDrug

    Also called Normal Saline

Study groups in NCT01738100
Study groupRoleWhat they receive
Ticagrelor + Intracoronary MorphineExperimental180 mg loading pre-PCI followed by 90 mg bid for 5 days. Intracoronary Morphine Sulfate 3 mg + Saline 3 ml mix.
Receives: Drug: Ticagrelor; Drug: Morphine Sulfate
Ticagrelor + Intracoronary SalineExperimental180 mg loading pre-PCI followed by 90 mg bid for 5 days. Saline 3 ml intracoronary injection.
Receives: Drug: Ticagrelor; Drug: Saline
Clopidogrel + Intracoronary MorphineExperimental600 mg loading pre-PCI followed by 75 mg qd for 5 days. Morphine Sulfate 3 mg + Saline 3 ml mix intracoronary injection.
Receives: Drug: Clopidogrel; Drug: Morphine Sulfate
Clopidogrel + Intracoronary SalineActive comparator600 mg loading pre-PCI followed by 75 mg qd for 5 days. Saline 3 ml intracoronary injection.
Receives: Drug: Clopidogrel; Drug: Saline

What is being measured

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

  1. Myocardial infarct size measured by magnetic resonance imaging (MRI) at 3-5 days after the index procedure

    Measured: Post-PCI 3-5 days

Secondary outcomes (7)

  1. Rate of complete ST-segment resolution on ECG obtained 30 minutes after the procedure

    Measured: 30 min after completion of PCI

  2. Enzymatic Infarct size by creatine kinase-MB (area under curve)

    Measured: 1 month later

  3. Myocardial salvage index measured by MRI

    Measured: Post-PCI 3-5 days

  4. Major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis)

    Measured: 1Month later

  5. The extent of microvascular obstruction measured by MRI

    Measured: post-PCI 3-5days

  6. The number of segments with >75% of infarct transmurality measured by MRI

    Measured: post-PCI 3-5 days

  7. The presence of myocardial hemorrhage measured by MRI

    Measured: post-PCI 3-5 days

Timeline

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

  1. First posted30 Nov 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (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
Factorial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738100
Sponsor's protocol ID
2012-08-010
Status last verified
Oct 2014
First submitted
23 Nov 2012
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Kim EK, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Chun WJ, Choe YH, Gwon HC, Hahn JY. Ticagrelor Versus Clopidogrel on Myocardial Infarct Size in Patients Undergoing Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Apr 25;69(16):2098-2099. doi: 10.1016/j.jacc.2017.02.034. No abstract available.

    PubMed 28427585

  • Gwag HB, Kim EK, Park TK, Lee JM, Yang JH, Song YB, Choi JH, Choi SH, Lee SH, Chang SA, Park SJ, Lee SC, Park SW, Jang WJ, Lee M, Chun WJ, Oh JH, Park YH, Choe YH, Gwon HC, Hahn JY. Cardioprotective Effects of Intracoronary Morphine in ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Prospective, Randomized Trial. J Am Heart Assoc. 2017 Apr 3;6(4):e005426. doi: 10.1161/JAHA.116.005426.

    PubMed 28373244

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ticagrelor, Clopidogrel and Morphine Sulfate in people with ST-Segment Elevation Myocardial Infarction, run by Hyeon-Cheol Gwon at 1 site in South Korea.

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 6 Jul 2016. 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 South Korea. 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 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?

Contact Hyeon-Cheol Gwon, MD/PhD (82-2-3410-6653, hcgwon62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial infarct size measured by magnetic resonance imaging (MRI) at 3-5 days after the index procedure (time frame: Post-PCI 3-5 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 NCT01738100, 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 6 Jul 2016.

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