Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 1054 for:    clopidogrel

Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis (TACAT)

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: NCT02048085
Recruitment Status : Withdrawn (unable to get study up and enrolling)
First Posted : January 29, 2014
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Rakesh K. Sharma, Medical Center of South Arkansas

Brief Summary:
This study involves doing platelet function testing in patients who have undergone fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of care to restore blood flow in blocked arteries as soon as possible after the "Heart attack" in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the damage of the myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing fibrinolysis has been well studied in many trials. In this study investigators will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs (Pharmacokinetics).

Condition or disease Intervention/treatment Phase
Acute ST Segment Elevation Myocardial Infarction Acute Coronary Syndrome Drug: Ticagrelor Drug: Clopidogrel Phase 4

Detailed Description:
This is an open label randomized pharmacodynamics study to compare platelet function reactivity of ticagrelor and clopidogrel after PCI in sub-set of patients who have undergone fibrinolysis at least 24 hour prior to PCI..A total of 70 patients will be enrolled. Prior to enrollment, patients have already undergone fibrinolysis (selected by the treating physician), aspirin (recommended dose 324 mg) on the first day and 81 mg daily thereafter, and Lovenox or heparin as per protocol of referring ER. Patients will undergo coronary angiography as standard of care and coronary stenting if indicated. Prior to angiography patient will be enrolled in this open label randomized protocol to receive clopidogrel or ticagrelor. Patients will be randomly assigned in a 1:1 ratio by open label study to receive either clopidogrel (Plavix, Sanofi-Aventis and Bristol-Myers Squibb; a 300-mg loading dose followed by 75 mg once daily) or ticagrelor (Brilinta, AstraZeneca; 180 mg loading and 90 mg twice daily) by a computerized system of randomization. Patients will receive clopidogrel or ticagrelor daily from enrollment to discharge. For patients who did not undergo PCI after enrollment, study drugs will be administered up to and including day 8th or hospital discharge, whichever comes first. Patients will be treated as per standard of care, and pharmacodynamics and pharmacokinetic study will be carried as per protocol. VerifyNow and VASP assay will be used to measure platelet reactivity for pharmacodynamic evaluation of ticagrelor vs Clopidogrel at specific time points: baseline (time 0), 30 mins, 1 hour, 2 hours, 8 hours and at 24 hours from first oral anti-platelet dose.. Blood will be collected from the sheath or ante-cubital vein into Vacutainer tubes for platelet function assay as below by VerifyNow and VASP. VerifyNow P2Y12 Assay: VerifyNow is a turbidimetric based system that measures platelet aggregation in the whole blood.8 This instrument measures an optical signal reported as P2Y12 Reaction Units (PRU). Vasodilator-Stimulated Phosphoprotein Phosphrylation (VASP) Assay: The measure of Vasodilator-Stimulated Phosphoprotein Phosphrylation (Biocytex Inc. Marseille, France), a method to quantify P2Y12 receptor reactivity, which reflects the extent of blockade of P2Y12 receptor blockade.9 Platelet reactivity index (PRI) is calculated by measuring VASP-P levels by mean fluorescence intensity (MFI) by stimulation with prostaglandin; PGE1and PGE1 plus ADP. PRI(%)=[(MFIPGE1)−(MFIPGE1+ADP)/(MFIPGE1)]×100%. ) Pharmacokinetic will be done at 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours. AUC from time 0-2 hours, Cmax at 2 hours, and Tmax at 2 hours for key secondary endpoint. Will collect Cmax and Tmax at all time points to be consistent, i.e. at 0, 30 min, 1 hour, 2 hour, 8 hours, and 24 hours when you draw PD measures at those time points and sample will be shipped.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized, Open Label, Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay; and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours
Estimated Study Start Date : January 2, 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ticagrelor
Ticagrelor Arm will be dosed with a loading dose of 180 mg followed by maintenance dose of 90 mg BID until discharge or up to 8 days.
Drug: Ticagrelor
For ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid.
Other Name: Brilinta

Active Comparator: Clopidogrel
Clopidogrel arm will be dose with a loading dose of 300 mg followed by maintenance dose of 75 mg everyday until discharge or up to 8 days.
Drug: Clopidogrel
For clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD
Other Name: Plavix




Primary Outcome Measures :
  1. Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow [ Time Frame: Change from baseline at 2 hours ]
    Pharmacodynamics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours


Secondary Outcome Measures :
  1. Pharmacokinetic (AUC, Cmax, Tmax) [ Time Frame: Change from baseline at 2 hours ]
    Pharmacokinetics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women 18 to 75 years of age
  2. Ischemic discomfort lasting more than 20 mins at rest within 12 hours before randomization
  3. ST-segment elevation of at least 0.1 mV in at least two contiguous limb leads, ST-segment elevation of at least 0.2 mV in at least two contiguous precordial leads, or left bundle-branch block that was not known to be old
  4. Received fibrinolytic agent, an anticoagulant (if a fibrin-specific lytic agent was prescribed) and aspirin within 24-48 hours

Exclusion Criteria:

  1. Hypersensitivity to ticagrelor or clopidogrel
  2. Active Pathological Bleeding or history of intracranial bleeding
  3. Concomitant use of oral anticoagulant
  4. Concomitant use of 40 mg of Simvastatin or lovastatin
  5. Concomitant strong CYP3A inhibitors such as ketoconazole, clarithromycin, nefazadone, ritonavir, atazanavir
  6. Concomitant use of CYP2C19 inhibitors such as omeprazole or esomeprazole
  7. Patients planned to urgent CABG
  8. Thrombocytopenia
  9. Dialysis
  10. Use of oral antiplatelet agent (ticagrelor, prasugrel, Clopidogrel) within 7 days prior to enrollment
  11. Use of GP IIb/IIIa inhibitors
  12. Rescue PCI (PCI < 24 hours from symptom onset) -

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): NCT02048085


Locations
Layout table for location information
United States, Arkansas
Medical Center of South Arkansas
El Dorado, Arkansas, United States, 71730
Sponsors and Collaborators
Medical Center of South Arkansas
Investigators
Layout table for investigator information
Principal Investigator: Rakesh K Sharma, MD, FACC, FSCAI, FSCCT Medical Center of South Arkansas

Layout table for additonal information
Responsible Party: Rakesh K. Sharma, Chief of Medicine, Adjunct Clinical Professor of Medicine and Cardiology, Medical Center of South Arkansas
ClinicalTrials.gov Identifier: NCT02048085     History of Changes
Other Study ID Numbers: ISSBRIL0224
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Keywords provided by Rakesh K. Sharma, Medical Center of South Arkansas:
ACS
STEMI
Fibrinolysis
Pharmacodynamics
Pharmacokinetics
Plavix
Brilinta
Ticagrelor
Clopidogrel
Additional relevant MeSH terms:
Layout table for MeSH terms
Clopidogrel
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs