- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748330
Platelet Inhibition of Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients After Elective Percutaneous Coronary Intervention (PLATIDE-PCI)
March 19, 2019 updated by: Peking Union Medical College Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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:
- 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.
- 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.).
- History of intolerance to ASA, Clopidogrel or Ticagrelor.
- Patients that are scheduled for CABG during the study period.
- 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.
- 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).
- Participation in another investigational drug or device study within 30 days of screening.
- Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff).
- History of drug addiction or alcohol abuse in the previous 2 years.
- Recent (within 30 days of screening) blood donation.
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Ticagrelor
Other Names:
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
|
Clopidogrel
Other Names:
Acetylsalicylic acid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15±2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15±2 days
|
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
|
15±2 days
|
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
|
15±2 days
|
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
|
15±2 days
|
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
|
15±2 days
|
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.
|
15±2 days
|
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.
|
15±2 days
|
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.
|
15±2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shuyang Zhang, M.D., Peking Union Medical College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Maddox TM, Reid KJ, Spertus JA, Mittleman M, Krumholz HM, Parashar S, Ho PM, Rumsfeld JS. Angina at 1 year after myocardial infarction: prevalence and associated findings. Arch Intern Med. 2008 Jun 23;168(12):1310-6. doi: 10.1001/archinte.168.12.1310.
- Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- 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, Sabate 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, Ryden 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. No abstract available. Erratum In: Eur Heart J. 2014 Sep 1;35(33):2260-1.
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- Schneider DJ. Factors contributing to increased platelet reactivity in people with diabetes. Diabetes Care. 2009 Apr;32(4):525-7. doi: 10.2337/dc08-1865. No abstract available.
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimate)
April 22, 2016
Study Record Updates
Last Update Posted (Actual)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- HS-873
- ESR-14-10403 (Other Grant/Funding Number: AstraZeneca)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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