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Reversal of the Anti-platelet Effects of Ticagrelor (REVERSAL)

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ClinicalTrials.gov Identifier: NCT02383771
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to determine the proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of ticagrelor and aspirin in healthy persons and patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ticagrelor Drug: Aspirin + Ticagrelor Drug: Control Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Reversal of the Anti-platelet Effects of Ticagrelor in Healthy Persons and Patients With Coronary Artery Disease
Study Start Date : March 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Anti-platelet Treatment
Ticagrelor
Drug: Ticagrelor
(Ticagrelor 90mg Bid) x 7days
Other Name: Brilinta

Experimental: Dual Anti-platelet Treatment
Aspirin + Ticagrelor
Drug: Aspirin + Ticagrelor
(Aspirin 100mg daily + Ticagrelor 90mg Bid) x 7days
Other Name: Brilinta

Sham Comparator: Control
No Drug
Drug: Control
No Anti-platelet Therapy

CAD undergoing PCI
Patients with coronary artery disease undergoing percutaneous coronary intervention and receiving dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily)
Drug: Aspirin + Ticagrelor
Dual anti-platelet therapy (Aspirin 100mg daily + Ticagrelor 90mg Bid) after percutaneous coronary intervention (PCI)
Other Name: Brilinta




Primary Outcome Measures :
  1. Reversal of the platelet inhibitory effects of antiplatelet therapy in healthy volunteers [ Time Frame: 7 days after randomization ]
    Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy

  2. Reversal of the platelet inhibitory effects of antiplatelet therapy in patients [ Time Frame: 7 days after percutaneous coronary intervention ]
    Reversal of the platelet inhibitory effects of antiplatelet therapy Proportion of untreated donor platelets required to fully reverse the platelet inhibitory effects of antiplatelet therapy in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and receiving ticagrelor


Secondary Outcome Measures :
  1. Inhibition of platelet aggregation in response to AA or ADP [ Time Frame: 7 days after randomization ]
    Inhibition of platelet aggregation (IPA) in response to 5μM ADP determined by light transmittance aggregometer (LTA) after 7-day ticagrelor administration

  2. Change of ADP-induced platelet aggregation in platelets saved in blood bank due to the saving time [ Time Frame: 5 days after fresh platelet collected and stored in blood bank ]
    How the ADP-induced platelet aggregation in platelets saved in blood bank changes due to the saving time



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Cohort 1:

Inclusion Criteria:

  • Healthy volunteers;
  • Subjects aged >18 years old;

Exclusion Criteria:

  • Allergy or intolerance to aspirin or ticagrelor;
  • Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L);
  • Subjects with anemia;
  • Subjects with bronchial asthma or chronic obstructive pulmonary disease;
  • Subjects with bradycardia (e.g. sick sinus syndrome, high-grade atrioventricular block, history of syncope with unproved uncorrelation with bradycardia);
  • Smokers;
  • Subjects with diabetes mellitus;
  • Subjects planning to be pregnancy;
  • Subjects with hepatic or renal dysfunction;
  • Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during study period.

Cohort 2:

Inclusion Criteria:

  • Subjects with diagnosed coronary artery disease undergoing percutaneous coronary intervention (PCI);
  • Subjects who have received dual anti-platelet therapy (ticagrelor 90mg bid + aspirin 100mg daily) for 7 days;

Exclusion Criteria:

  • Subjects at a high risk of bleeding (e.g. platelet count<100×10^9/L, history of peptic ulcer, hemoglobin<110g/L);
  • Subjects with anemia;
  • Smokers
  • Subjects planning to be pregnancy;
  • Subjects with hepatic or renal dysfunction;
  • Subjects who have taken other anti-platelet drugs, non-steroidal anti-inflammatory drugs or proton pump inhibitors before scanning or need to take them during 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): NCT02383771


Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
National Natural Science Foundation of China
Investigators
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Principal Investigator: Chunjian Li, Ph.D The First Affiliated Hospital with Nanjing Medical University

Publications:
Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE Jr, Green LA, Hochman JS, Jacobs AK, Krumholz HM, Morrison DA, Ornato JP, Pearle DL, Peterson ED, Sloan MA, Whitlow PL, Williams DO. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update) a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009 Dec 1;54(23):2205-41. doi: 10.1016/j.jacc.2009.10.015. Review. Erratum in: J Am Coll Cardiol. 2009 Dec 15;54(25):2464. J Am Coll Cardiol. 2010 Feb 9;55(6):612. Dosage error in article text.

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Responsible Party: Chunjian Li, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02383771     History of Changes
Other Study ID Numbers: 003
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University:
Ticagrelor
Aspirin
Peri-operative treatment
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents