Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI

NCT02233790 | Unknown Phase 4 DMC

• 1 other identifier: ISSBRIL0209
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The patients with acute myocardial infarction (AMI) present high mortality and morbidity rate,even treated with stenting in the blocked heart vessels. The appearance of no-reflow is common after re-opening of the blocked vessel. The no-reflow were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and spasm of the micro-vessel during stenting. An agent with more effective anti-clotting and micro-vessel dilation would be helpful to solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous potent small vessel dilator. This study is to test the effectiveness of ticagrelor on improving reperfusion and minimizing the myocardial infarct size after PPCI in patients with AMI.

Conditions

Myocardial Infarction; No-Reflow Phenomenon

Keywords

Myocardial infarction; No-Reflow Phenomenon; Ticagrelor; Clopidogrel; Single-Photon Emission Computerized Tomography

Outcome Measures

Primary Outcomes (1)

• myocardial infarcted size

  To evaluate the infarcted size on Day 7 after PPCI by SPECT.

  1 week

Secondary Outcomes (1)

• elevated ST segment resolution

  1 hour and 24 hours

Other Outcomes (1)

• severe brachycardia arrhythmia

  1 month

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

a loading dose of 180mg pre-PCI, and then 90 mg twice daily for 1 Month within the study. Thereafter, the patients will take clopidogrel if Ticagrelor is not available on the market.

Also known as: Brilinta

Ticagrelor

Clopidogrel DRUG

Clopidogrel 75 mg once daily after a loading dose of 300 mg pre-PCI.

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Patients with acute ST-segment elevation myocardial infarction, an onset of symptoms presented within 12 hours. Two criteria have to be met: persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block, and the intention to perform primary PCI
• Patients must agree to undergo all protocol-required follow-up examinations and not to participate any other clinical trials within the duration of this study

You may not qualify if:

• Any contraindication against the use of clopidogrel or ticagrelor
• Fibrinolytic therapy within 24 hours before randomization
• Stroke within the previous 6 months or intracranial hemorrhage at any time before randomization
• Any other concomitant severe organic or systemic disorder, such as severe liver (ALT\>3×ULN )or renal disease(creatinin\>5.0mg/dl or 442μmol/L), etc.
• A need for oral anticoagulation therapy
• An increased risk of bradycardia or atrial-ventricle block
• Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
• Pregnant women or breast-feeding, or planning to become pregnant while enrolled in this study
• Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Sponsors & Collaborators

• First Hospital of China Medical University: lead
• AstraZeneca: collaborator

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Related Publications (4)

• Mahaffey KW, Puma JA, Barbagelata NA, DiCarli MF, Leesar MA, Browne KF, Eisenberg PR, Bolli R, Casas AC, Molina-Viamonte V, Orlandi C, Blevins R, Gibbons RJ, Califf RM, Granger CB. Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction: results of a multicenter, randomized, placebo-controlled trial: the Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial. J Am Coll Cardiol. 1999 Nov 15;34(6):1711-20. doi: 10.1016/s0735-1097(99)00418-0.

  PMID: 10577561 BACKGROUND

• Steg PG, James S, Harrington RA, Ardissino D, Becker RC, Cannon CP, Emanuelsson H, Finkelstein A, Husted S, Katus H, Kilhamn J, Olofsson S, Storey RF, Weaver WD, Wallentin L; PLATO Study Group. Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis. Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8.

  PMID: 21060072 BACKGROUND

• Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.

  PMID: 19923168 BACKGROUND

• Ross AM, Gibbons RJ, Stone GW, Kloner RA, Alexander RW; AMISTAD-II Investigators. A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II). J Am Coll Cardiol. 2005 Jun 7;45(11):1775-80. doi: 10.1016/j.jacc.2005.02.061.

  PMID: 15936605 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; No-Reflow Phenomenon

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yingxian Sun, Dr.

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingxian Sun, Dr.

CONTACT

0086-24-83282688; sunyingxian12@126.com

Wen Tian, Dr.

CONTACT

0086-24-83282300; dr.wentian@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of cardiology

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 8, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

CN (1)