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Completed

NCT Number: NCT01962428

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

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.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of Chinese People's Armed Police Forces, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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 2h-72h 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, 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 and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor

Drug

Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Other names: Brilinta

Primary outcomes

  1. Platelet Reactivity Index(PRI) Measured by VASP-P

    Time frame: 2 hours after the loading dose of ticagrelor

    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).

Secondary outcomes

  1. Platelet Reactivity Index (PRI) Measured by VASP-P

    Time frame: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor

  2. Bleeding Events

    Time frame: follow-up for 28 days after the loading dose of ticagrelor

Sponsors and collaborators

Lead sponsor

General Hospital of Chinese Armed Police Forces

Other

Registry information

Official study title

Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2013
Registry last updated
Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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