Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03062462
Status:
UNKNOWN
Last Update Posted:
2018-05-07
First Post:
2017-02-20
Brief Title:
Half-dose Ticagrelor Overcomes High-dose Clopidogrel in Acute Coronary Syndrome Patients With High On-Clopidogrel Platelet Reactivity
Sponsor:
First Affiliated Hospital of Harbin Medical University
Organization:
First Affiliated Hospital of Harbin Medical University
Study Overview
Official Title:
Half-dose Ticagrelor Overcomes High-dose Clopidogrel in Acute Coronary Syndrome Patients With High On-Clopidogrel Platelet Reactivity
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
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:
With the widespread use of clopidogrel resistance to clopidogrel has been attracting increasing attention and emerged as a new challenge adversely affecting patients clinical risk and outcome Clopidogrel resistance means that blood platelets show little or no response to clopidogrel It is closely associated with increased risk of serious cardiovascular events seriously affects the prognosis of patients and brings difficulties to clinical treatment
Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor which was significantly stronger than that in the clopidogrel group But it is still not very clear that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel resistance and coronary heart disease
Therefore we performed this randomized single-blind clinical trial to observe the effects of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and prognosis in clopidogrel resistances patients with coronary heart disease
Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor which was significantly stronger than that in the clopidogrel group But it is still not very clear that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel resistance and coronary heart disease
Therefore we performed this randomized single-blind clinical trial to observe the effects of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and prognosis in clopidogrel resistances patients with coronary heart disease
Detailed Description:
Dual Antiplatelet Therapy DAPT with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease CAD Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y12 adenosine diphosphate ADP receptor With the widespread use of clopidogrel resistance to clopidogrel has been attracting increasing attention and emerged as a new challenge adversely affecting patients clinical risk and outcome Clopidogrel resistance means that blood platelets show little or no response to clopidogrel Recent studies have found that clopidogrel resistance rate was about 11 44 Clopidogrel resistance is more common in patients with loss-of-function CYP2C19 genotypes and closely associated with increased risk of serious cardiovascular events including ischemic events myocardial infarction stent thrombosis revascularization and so on This seriously affects the prognosis of patients and brings difficulties to clinical treatment
Ticagrelor is an oral reversibly-binding direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes ACS Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor which was significantly stronger than that in the clopidogrel group But it is still not very clear that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel resistance and coronary heart disease
Therefore we performed this randomized single-blind clinical trial to observe the effects of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and cardiovascular prognosis in clopidogrel resistances patients with coronary heart disease
Ticagrelor is an oral reversibly-binding direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes ACS Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor which was significantly stronger than that in the clopidogrel group But it is still not very clear that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel resistance and coronary heart disease
Therefore we performed this randomized single-blind clinical trial to observe the effects of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and cardiovascular prognosis in clopidogrel resistances patients with coronary heart disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None