Platelet Inhibition of Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients After Elective Percutaneous Coronary Intervention

NCT02748330 | Completed Phase 4

• 2 other identifiers: HS-873ESR-14-10403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single-center, randomized, open-label, active-controlled, parallel-group study to investigate the platelet inhibition of Ticagrelor versus Clopidogrel with acetylsalicylic acid (ASA) as background therapy in approximate 40 patients with stable coronary artery disease (SCAD) and type 2 diabetes mellitus (DM) after recent successful elective percutaneous coronary intervention (PCI) by evaluation of the P2Y12 reaction unit (PRU) by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on treatment day 15±2.

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• P2Y12 reaction unit (PRU)

  The PRU by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2

  15±2 days

Secondary Outcomes (8)

• P2Y12 reaction unit (PRU) (before)

  15±2 days

• Percent inhibition (% Inhibition)

  15±2 days

• Percent inhibition (% Inhibition) (before)

  15±2 days

• High on-treatment platelet reactivity (HOPR)

  15±2 days

• High on-treatment platelet reactivity (HOPR) (before)

  15±2 days

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Oral ticagrelor 90 mg tablet, twice daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days

Drug: Ticagrelor; Drug: Aspirin

Clopidogrel

ACTIVE COMPARATOR

Oral clopidogrel 75 mg tablet, once daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days

Drug: Clopidogrel; Drug: Aspirin

Interventions

Ticagrelor DRUG

Ticagrelor

Also known as: Brilinta

Ticagrelor

Clopidogrel DRUG

Clopidogrel

Also known as: Plavix

Clopidogrel

Aspirin DRUG

Acetylsalicylic acid

Clopidogrel; Ticagrelor

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent (by patient or appropriate designee according to local regulations) prior to any study specific procedures.
• Aged 18 years or older, male or female.
• Documented stable coronary artery disease (CAD) fulfilling any of the following:
• History of stable angina pectoris with angiographic evidence of CAD (diameter stenosis ≥ 50%) in major, i.e., left main, left anterior descending, left circumflex, and right coronary arteries.
• History of previous myocardial infarction (MI)
• History of coronary revascularization, i.e., percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG), not including the elective PCI during the index hospitalization
• Documented history of type 2 diabetes mellitus.
• At least 24 hours after but within 14 days of angiographically successful elective PCI without complications.
• Post-procedural residual diameter stenosis of the treated lesions \< 20% in patients with stent implantation or \< 50% in those with balloon angioplasty
• Post-procedural thrombolysis in myocardial infarction (TIMI) grade 3 flow in treated vessels
• Negative cardiac troponin test before the index elective PCI.
• Taking Clopidogrel 75 mg daily dose for at least 7 days or taking Clopidogrel 75 mg daily dose for less than 7 days but with 300 to 600 mg Clopidogrel loading dose before PCI.
• Taking acetylsalicylic acid (ASA) 100 mg daily treatment for at least 7 days or taking ASA 100 mg daily dose for less than 7 days but with 300 mg ASA loading dose before PCI.
• Females with childbearing potential (i.e., females who are not post-menopausal or surgically sterile) must:
• have a negative urine or blood pregnancy test at enrolment and prior to randomization;

You may not qualify if:

• Patients who had acute coronary syndrome (ACS) within 12 months of screening.
• Occurrence of myocardial infarction (MI) related to index elective PCI (type 4a MI) or myocardial infarction related to stent thrombosis (type 4b MI) according to the Third Universal Definition of Myocardial Infarction.
• Use of parenteral antithrombotic agents, e.g., glycoprotein IIb/IIIa inhibitors (GPIs), bivalirudin, unfractionated heparin, enoxaparin or fondaparinux within 24 hours of screening.
• Use of any oral antithrombotic agents, with the exception of Clopidogrel and ASA, within 30 days of screening.
• Any other indications (e.g., atrial fibrillation, prosthetic heart valve, venous thromboembolism, ventricular thrombosis, et al) for antithrombotic treatment other than ASA 100 mg daily, Clopidogrel and Ticagrelor during study period.
• Concomitant therapy with moderate or strong cytochrome P-450 (CYP) 3A inhibitors, CYP 3A substrates with narrow therapeutic index, or strong CYP 3A inducers during study period.
• Concomitant therapy with moderate or strong CYP 2C19 inhibitors, CYP 2C19 substrates with narrow therapeutic index, or strong CYP 2C19 inducers during study period.
• Increased bleeding risk including:
• recent (within 30 days of screening) gastrointestinal (GI) bleeding;
• any history of intracranial, intraocular, retroperitoneal, or spinal bleeding;
• recent (within 30 days of screening) major trauma or major surgery;
• sustained uncontrolled hypertension (systolic blood pressure \[SBP\] \> 180 mmHg or diastolic blood pressure \[DBP\] \> 100 mmHg);
• history of hemorrhagic disorders that can increase the risk of bleeding, e.g., haemophilia, von Willebrand's disease;
• inability to discontinue required concomitant therapy with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) at screening;
• platelet count less than 100,000/mm3 or hemoglobin \< 10 g/dL.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (57)

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• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.

  PMID: 22922414 RESULT

• Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

  PMID: 19717846 RESULT

• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

  PMID: 25173339 RESULT

• Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.

  PMID: 17982182 RESULT

• Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.

  PMID: 11519503 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Interventions

Ticagrelor; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Shuyang Zhang, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 22, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2017-12

Locations

CN (1)