Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

This study is not yet open for participant recruitment.
Verified October 2013 by General Hospital of Chinese Armed Police Forces
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01962428
First received: October 10, 2013
Last updated: October 25, 2013
Last verified: October 2013

October 10, 2013
October 25, 2013
December 2013
December 2014   (final data collection date for primary outcome measure)
platelet reactivity index(PRI) measured by VASP-P [ Time Frame: 2 hours after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
Same as current
Complete list of historical versions of study NCT01962428 on ClinicalTrials.gov Archive Site
  • platelet reactivity index (PRI) measured by VASP-P [ Time Frame: 0.5hour,1hour,4hours,8hours,24hours after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]
  • bleeding events [ Time Frame: follow-up for 1 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention

It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.

After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 12h-24h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 4, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h, 8h and 24h after PCI. Patients returned 1 month for follow-up visits, documented any adverse events.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non ST Segment Elevation Acute Coronary Syndrome
Drug: ticagrelor
Other Name: Brilinta
  • Experimental: high loading dose of ticagrelor
    Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
    Intervention: Drug: ticagrelor
  • Active Comparator: conventional loading dose of ticagrelor
    Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
    Intervention: Drug: ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
242
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Male or non-pregnant female; aged from 18 to 80 years old.
  • Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria:

  • Any contraindication against the use of ticagrelor.
  • On treatment with a P2Y12 receptor antagonist in past 30 days.
  • Known allergies to aspirin or ticagrelor.
  • On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
  • Known blood dyscrasia or bleeding diathesis.
  • ST-segment elevation acute myocardial infarction.
  • Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
  • Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
Both
18 Years to 80 Years
No
Contact: Huiliang Liu, Doctor 86-10-57976531 lhl518@vip.sina.com
Contact: Yujie Wei, Doctor 86-10-57976707
China
 
NCT01962428
ISSBRIL0214
Yes
General Hospital of Chinese Armed Police Forces
General Hospital of Chinese Armed Police Forces
Not Provided
Principal Investigator: Huiliang Liu, Doctor Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
General Hospital of Chinese Armed Police Forces
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP