Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02219412
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2014-07-24
Brief Title:
Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable CAD Treated With Ticagrelor Monotherapy
Sponsor:
Yong Huo
Organization:
Peking University First Hospital
Study Overview
Official Title:
An Open Label Two Arms Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirinticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease The potential hypothesis is that the arachidonic acid AA induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirinticagrelor dual-therapy
Detailed Description:
This is a randomized open labeled active-controlled pilot study to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor monotherapy and aspirinticagrelor dual-therapy in patients with stable coronary heart disease The anticipated duration of the study is approximately 9 months including an anticipated enrolment period of 8 months and follow-up period of 4weeks
Patients with documented coronary heart disease and currently receiving dual-antiplatelet therapy with standard dose aspirin and clopidogrel will be enrolled from the study site For patients post acute coronary syndrome ACS or percutaneous coronary intervention PCI they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study
The study plan including enrolmentrandomization and follow-up visits is outlined in Table 1 Eligible patients will enter a washout phase with ticagrelor for 2 weeks Then they will be randomized to take either ticagrelor alone or aspirinticagrelor for 14 days The efficacy evaluation will be done at 7 and 14days after randomization The primary efficacy parameter is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment All patients will be treated to standards of care for coronary heart disease secondary prevention
Visit 0 Screening and Enrollment 0 day All potentially eligible patients will undergo a screening visit following their signed informed consent
Following an 8-hour fast the patients will have screening evaluations performed Demography medical history and concomitant medication will be recorded A physical examination and vital signspulse and BP height and weight as well as blood sampling for laboratory assessments of complete blood count CBC with differential serum creatinine alanine aminotransferase ALT and aspartate aminotransferase AST and AA adenosine diphosphate ADP and collagen induced platelet aggregation rate will be done Standard 12-lead electrocardiogram ECG readings will be recorded
Patients meeting all inclusion criteria and with no exclusion criteria will be enrolled Patients will receive ticagrelor mono-therapy from the evening for 14 days IP will be dispensed
Visit 1 Randomization 14 days Suspected adverse events AEs will be recorded A physical examination and vital signs pulse and BP as well as blood sampling for laboratory assessments of AA ADP and collagen induced platelet aggregation rate and serum thromboxane B2 concentration will be done
Patients should be told to take ticagrelor in the morning of Visit 1 Patients will be randomized in a 11 ratio to receive either ticagrelor mono-therapy or aspirinticagrelor dual-therapy Investigational product IP will be returned and compliance assessed and new bottles of IP will be dispensed according to randomized groups
Visit 2 21 days Suspected AEs will be recorded Vital signs pulse and BP as well as blood sampling for laboratory assessments of AA ADP and collagen induced platelet aggregation rate will be done
Visit 3 End of treatment 28 days Suspected AEs will be recorded Vital signs pulse and BP as well as blood sampling for laboratory assessments of CBC with differential Scr ALT and AST AA ADP and collagen induced platelet aggregation rate will be done IP will be returned and compliance assessed Instructions for medication after study will be given to patients at this time
For patients who prematurely discontinued the randomized treatment a complete end of treatment visit will be preferred
Patients with documented coronary heart disease and currently receiving dual-antiplatelet therapy with standard dose aspirin and clopidogrel will be enrolled from the study site For patients post acute coronary syndrome ACS or percutaneous coronary intervention PCI they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study
The study plan including enrolmentrandomization and follow-up visits is outlined in Table 1 Eligible patients will enter a washout phase with ticagrelor for 2 weeks Then they will be randomized to take either ticagrelor alone or aspirinticagrelor for 14 days The efficacy evaluation will be done at 7 and 14days after randomization The primary efficacy parameter is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment All patients will be treated to standards of care for coronary heart disease secondary prevention
Visit 0 Screening and Enrollment 0 day All potentially eligible patients will undergo a screening visit following their signed informed consent
Following an 8-hour fast the patients will have screening evaluations performed Demography medical history and concomitant medication will be recorded A physical examination and vital signspulse and BP height and weight as well as blood sampling for laboratory assessments of complete blood count CBC with differential serum creatinine alanine aminotransferase ALT and aspartate aminotransferase AST and AA adenosine diphosphate ADP and collagen induced platelet aggregation rate will be done Standard 12-lead electrocardiogram ECG readings will be recorded
Patients meeting all inclusion criteria and with no exclusion criteria will be enrolled Patients will receive ticagrelor mono-therapy from the evening for 14 days IP will be dispensed
Visit 1 Randomization 14 days Suspected adverse events AEs will be recorded A physical examination and vital signs pulse and BP as well as blood sampling for laboratory assessments of AA ADP and collagen induced platelet aggregation rate and serum thromboxane B2 concentration will be done
Patients should be told to take ticagrelor in the morning of Visit 1 Patients will be randomized in a 11 ratio to receive either ticagrelor mono-therapy or aspirinticagrelor dual-therapy Investigational product IP will be returned and compliance assessed and new bottles of IP will be dispensed according to randomized groups
Visit 2 21 days Suspected AEs will be recorded Vital signs pulse and BP as well as blood sampling for laboratory assessments of AA ADP and collagen induced platelet aggregation rate will be done
Visit 3 End of treatment 28 days Suspected AEs will be recorded Vital signs pulse and BP as well as blood sampling for laboratory assessments of CBC with differential Scr ALT and AST AA ADP and collagen induced platelet aggregation rate will be done IP will be returned and compliance assessed Instructions for medication after study will be given to patients at this time
For patients who prematurely discontinued the randomized treatment a complete end of treatment visit will be preferred
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None