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Trial record 12 of 512 for:    ASPIRIN AND P2

Platelet Inhibition of Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients After Elective Percutaneous Coronary Intervention (PLATIDE-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748330
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus, Type 2 Drug: Ticagrelor Drug: Clopidogrel Drug: Aspirin Phase 4

Detailed Description:
The study will consist of a screening period, a 15±2 day treatment period, and a 7 day follow-up period. The screening period will be up to 7 days. Once each patient has signed the informed consent, the eligibility of the patient will be determined at screening, and laboratory assessments will be taken (Visit 1). During the treatment period, patients participating in the study will be randomized to receive either Ticagrelor with ASA, or Clopidogrel with ASA for 15±2 days. The final dose of study medication will be administered at the study site in the morning of day 15±2. Study visits at the beginning (Visit 2) and the end of the treatment period (Visit 4) will allow assessment of platelet function. At 7±1 days after Visit 2, a telephone visit (Visit 3) will be carried out for collection of information on concomitant medication, adverse events (including vascular events), and safety end point events. After the platelet function tests at Visit 4 are finished, patients in both groups will discontinue their study medication (end of treatment, EOT). A follow-up period will begin at 1 day after Visit 4 and continue for 7 days. During the follow-up period, patients in Ticagrelor group will take Clopidogrel 600 mg loading dose on the first day, followed by Clopidogrel 75 mg maintenance dose from the second day for 6 days; patients in Clopidogrel group will continue taking Clopidogrel 75 mg maintenance dose for 7 days. Both adverse events (including vascular events) and safety end point events will be collected at the safety visit (Visit 5), which will occur 7 days after Visit 4. The study will last approximately 4 weeks per patient. After the informed consents are signed by the patients, all adverse events (including vascular events), safety end point events and concomitant medications will be recorded at each visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Active-controlled, Parallel-group Study to Investigate the Platelet Inhibition of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease and Type 2 Diabetes Mellitus After Recent Elective Percutaneous Coronary Intervention
Study Start Date : June 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ticagrelor
Oral ticagrelor 90 mg tablet, twice daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days
Drug: Ticagrelor
Ticagrelor
Other Name: Brilinta

Drug: Aspirin
Acetylsalicylic acid

Active Comparator: Clopidogrel
Oral clopidogrel 75 mg tablet, once daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days
Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Acetylsalicylic acid




Primary Outcome Measures :
  1. P2Y12 reaction unit (PRU) [ Time Frame: 15±2 days ]
    The PRU by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2


Secondary Outcome Measures :
  1. P2Y12 reaction unit (PRU) (before) [ Time Frame: 15±2 days ]
    The PRU by VerifyNow P2Y12 assay before the first study drug dose on day 15±2

  2. Percent inhibition (% Inhibition) [ Time Frame: 15±2 days ]
    The % Inhibition by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2

  3. Percent inhibition (% Inhibition) (before) [ Time Frame: 15±2 days ]
    The % Inhibition by VerifyNow P2Y12 assay before the first study drug dose on day 15±2

  4. High on-treatment platelet reactivity (HOPR) [ Time Frame: 15±2 days ]
    The rate of HOPR by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2

  5. High on-treatment platelet reactivity (HOPR) (before) [ Time Frame: 15±2 days ]
    The rate of HOPR by VerifyNow P2Y12 assay before the first study drug dose on day 15±2

  6. Non-coronary artery bypass graft (CABG) related major bleeding [ Time Frame: 15±2 days ]
    The rate of non-CABG related major bleeding according to Platelet Inhibition and Patient Outcome (PLATO) study definition up to day 15±2.

  7. Non-coronary artery bypass graft (CABG) related major or minor bleeding [ Time Frame: 15±2 days ]
    The rate of non-CABG related major or minor bleeding according to PLATO definition up to day 15±2.

  8. Non-coronary artery bypass graft (CABG) related major or minor or minimal bleeding [ Time Frame: 15±2 days ]
    The rate of non-CABG related major or minor or minimal bleeding according to PLATO definition up to day 15±2.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent (by patient or appropriate designee according to local regulations) prior to any study specific procedures.
  2. Aged 18 years or older, male or female.
  3. 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
  4. Documented history of type 2 diabetes mellitus.
  5. 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
  6. Negative cardiac troponin test before the index elective PCI.
  7. 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.
  8. 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.
  9. 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;
    • currently be using a hormonal contraceptive and agree to continue its use in addition to using double-barrier local contraception (i.e., intra-uterine device plus spermicidal and condom for male partner) from screening through study completion.

Exclusion Criteria:

  1. Patients who had acute coronary syndrome (ACS) within 12 months of screening.
  2. 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.
  3. Use of parenteral antithrombotic agents, e.g., glycoprotein IIb/IIIa inhibitors (GPIs), bivalirudin, unfractionated heparin, enoxaparin or fondaparinux within 24 hours of screening.
  4. Use of any oral antithrombotic agents, with the exception of Clopidogrel and ASA, within 30 days of screening.
  5. 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.
  6. 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.
  7. Concomitant therapy with moderate or strong CYP 2C19 inhibitors, CYP 2C19 substrates with narrow therapeutic index, or strong CYP 2C19 inducers during study period.
  8. 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.
  9. Contraindication or other reason that ASA, Clopidogrel, or Ticagrelor should not be administered (e.g., hypersensitivity, active bleeding [including active pathological bleeding], any bleeding tendency [coagulation defects], moderate and severe hepatic impairment, risk of bradycardia, chronic obstructive pulmonary disease, chronic or active asthma, hyperuricemia, gout, etc.).
  10. History of intolerance to ASA, Clopidogrel or Ticagrelor.
  11. Patients that are scheduled for CABG during the study period.
  12. Patient requires dialysis or has a creatinine clearance (Clcr) < 30 mL/min as calculated by the Cockcroft-Gault equation: Clcr = (140 - Age) × WT / (72 × Scr) (× 0.85 for females), where WT is weight in kg, Scr is serum creatinine in mg/dL.
  13. Any acute or chronic unstable conditions in the past 30 days or other conditions which, in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g., active cancer, risk for non-compliance, risk for being lost to follow-up).
  14. Participation in another investigational drug or device study within 30 days of screening.
  15. Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff).
  16. History of drug addiction or alcohol abuse in the previous 2 years.
  17. Recent (within 30 days of screening) blood donation.
  18. Known pregnancy, breast-feeding, or intend to become pregnant during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748330


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Shuyang Zhang, M.D. Peking Union Medical College Hospital

Additional Information:
Publications of Results:
Task Force Members, Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabaté M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Rydén L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. Erratum in: Eur Heart J. 2014 Sep 1;35(33):2260-1.
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, Menasché 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.

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02748330    
Other Study ID Numbers: HS-873
ESR-14-10403 ( Other Grant/Funding Number: AstraZeneca )
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors