Effects of Ticagrelor on No-reflow in Patients With Acute ST-segment Elevation Myocardial Infarction

NCT02798874 | Unknown DMC

• 1 other identifier: 16qgyyq
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The 'no-reflow' phenomenon after a percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI) is a strong predictor of both short- and long-term mortality. Faster antiplatelet activity and increased levels of adenosine provide a theoretical basis for ticagrelor to effectively prevent no-reflow after PCI. We planned to evaluate the effects of ticagrelor on myocardial no-reflow after PCI for STEMI.

Conditions

Cardiovascular Diseases

Keywords

Ticagrelor; No-reflow; Acute ST-segment elevation myocardial; Reperfusion injury; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• the prevalence of no-reflow,

  Anterograde coronary flow in the infarct-related artery was graded according to the thrombolysis in myocardial infarction (TIMI) grading system

  immediately post procedure

Secondary Outcomes (1)

• main cardiovascular events

  90 days

Study Arms (2)

Ticagrelor Group

EXPERIMENTAL

ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery

Drug: Ticagrelor

Clopidogrel Group

ACTIVE COMPARATOR

Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery

Ticagrelor Group

Clopidogrel DRUG

Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery

Clopidogrel Group

Eligibility Criteria

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

You may qualify if:

• patients with STEMI who were admitted to the Chinese PLA General Hospital

You may not qualify if:

• unconscious at presentation; 2.had cardiogenic shock, 3.hypoglycemia, 4.diabetic ketoacidosis; 5.had a history of myocardial infarction, stent thrombosis, or renal insufficiency; 6.had previously undergone coronary artery bypass surgery.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (12)

• Rezkalla SH, Kloner RA. Coronary no-reflow phenomenon: from the experimental laboratory to the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):950-7. doi: 10.1002/ccd.21715.

  PMID: 19021281 BACKGROUND

• Bolognese L, Carrabba N, Parodi G, Santoro GM, Buonamici P, Cerisano G, Antoniucci D. Impact of microvascular dysfunction on left ventricular remodeling and long-term clinical outcome after primary coronary angioplasty for acute myocardial infarction. Circulation. 2004 Mar 9;109(9):1121-6. doi: 10.1161/01.CIR.0000118496.44135.A7. Epub 2004 Feb 16.

  PMID: 14967718 BACKGROUND

• Brosh D, Assali AR, Mager A, Porter A, Hasdai D, Teplitsky I, Rechavia E, Fuchs S, Battler A, Kornowski R. Effect of no-reflow during primary percutaneous coronary intervention for acute myocardial infarction on six-month mortality. Am J Cardiol. 2007 Feb 15;99(4):442-5. doi: 10.1016/j.amjcard.2006.08.054. Epub 2006 Dec 20.

  PMID: 17293180 BACKGROUND

• Reffelmann T, Kloner RA. The no-reflow phenomenon: A basic mechanism of myocardial ischemia and reperfusion. Basic Res Cardiol. 2006 Sep;101(5):359-72. doi: 10.1007/s00395-006-0615-2.

  PMID: 16915531 BACKGROUND

• Wang JW, Chen YD, Wang CH, Yang XC, Zhu XL, Zhou ZQ. Development and validation of a clinical risk score predicting the no-reflow phenomenon in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Cardiology. 2013;124(3):153-60. doi: 10.1159/000346386. Epub 2013 Mar 8.

  PMID: 23485798 BACKGROUND

• Chen Y, Wang C, Yang X, Wang L, Sun Z, Liu H, Chen L. Independent no-reflow predictors in female patients with ST-elevation acute myocardial infarction treated with primary percutaneous coronary intervention. Heart Vessels. 2012 May;27(3):243-9. doi: 10.1007/s00380-011-0144-2. Epub 2011 Apr 28.

  PMID: 21526420 BACKGROUND

• Wang J, Chen YD, Zhi G, Xu Y, Chen L, Liu HB, Zhou X, Tian F. Beneficial effect of adenosine on myocardial perfusion in patients treated with primary percutaneous coronary intervention for acute myocardial infarction. Clin Exp Pharmacol Physiol. 2012 Mar;39(3):247-52. doi: 10.1111/j.1440-1681.2012.05668.x.

  PMID: 22214231 BACKGROUND

• Teng R, Oliver S, Hayes MA, Butler K. Absorption, distribution, metabolism, and excretion of ticagrelor in healthy subjects. Drug Metab Dispos. 2010 Sep;38(9):1514-21. doi: 10.1124/dmd.110.032250. Epub 2010 Jun 15.

  PMID: 20551239 BACKGROUND

• Wittfeldt A, Emanuelsson H, Brandrup-Wognsen G, van Giezen JJ, Jonasson J, Nylander S, Gan LM. Ticagrelor enhances adenosine-induced coronary vasodilatory responses in humans. J Am Coll Cardiol. 2013 Feb 19;61(7):723-7. doi: 10.1016/j.jacc.2012.11.032. Epub 2013 Jan 9.

  PMID: 23312702 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

• Wang CH, Chen YD, Yang XC, Wang LF, Wang HS, Sun ZJ, Liu HB. A no-reflow prediction model in patients with ST-elevation acute myocardial infarction and primary drug-eluting stenting. Scand Cardiovasc J. 2011 Apr;45(2):98-104. doi: 10.3109/14017431.2011.558209. Epub 2011 Feb 17.

  PMID: 21329416 BACKGROUND

• Jogiya R, Kozerke S, Morton G, De Silva K, Redwood S, Perera D, Nagel E, Plein S. Validation of dynamic 3-dimensional whole heart magnetic resonance myocardial perfusion imaging against fractional flow reserve for the detection of significant coronary artery disease. J Am Coll Cardiol. 2012 Aug 21;60(8):756-65. doi: 10.1016/j.jacc.2012.02.075. Epub 2012 Jul 18.

  PMID: 22818072 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Reperfusion Injury

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Dai Yun Chen, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CN (1)