A Phase 4 interventional study of ticagrelor in Non ST Segment Elevation Acute Coronary Syndrome, sponsored by General Hospital of Chinese Armed Police Forces. Completed at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by General Hospital of Chinese Armed Police Forces · Phase 4, Interventional, and Treatment
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 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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 250 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →General Hospital of Chinese Armed Police Forces is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Drug: ticagrelor
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Drug: ticagrelor
Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Also known as: Brilinta
Platelet Reactivity Index(PRI) Measured by VASP-P
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).
Time frame: 2 hours after the loading dose of ticagrelor
Platelet Reactivity Index (PRI) Measured by VASP-P
Time frame: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor
Bleeding Events
Time frame: follow-up for 28 days after the loading dose of ticagrelor
A total of 278 patients were recruited at 8 centers in Beijing and allocated into two groups using block randomization: a high LD group (360 mg) and a conventional LD group (180 mg).
| Milestone | High Loading Dose of Ticagrelor | Conventional Loading Dose of Ticagrelor |
|---|---|---|
| Started | 139 | 139 |
| Completed | 129 | 133 |
| Not completed | 10 | 6 |
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).
| percentage of 100 | Conventional Loading Dose of Ticagrelor | High Loading Dose of Ticagrelor |
|---|---|---|
| Platelet Reactivity Index(PRI) Measured by VASP-P | 16.7 (4.3 to 21.3) | 12.2 (9.3 to 32.3) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Loading Dose of Ticagrelor | — | 3/139 (2.2%) | 15/139 (10.8%) |
| High Loading Dose of Ticagrelor | — | 5/139 (3.6%) | 19/139 (13.7%) |
| Event | Conventional Loading Dose of Ticagrelor | High Loading Dose of Ticagrelor |
|---|---|---|
| failure of PCICardiac disorders | 0/139 | 2/139 |
| aortic dissectionCardiac disorders | 1/139 | 0/129 |
| pericardial effusionCardiac disorders | 0/139 | 1/139 |
| deathCardiac disorders | 1/139 | 1/139 |
| AMIGastrointestinal disorders | 1/139 | 0/139 |
| gastrorrhagiaGastrointestinal disorders | 0/139 | 1/139 |
| Event | Conventional Loading Dose of Ticagrelor | High Loading Dose of Ticagrelor |
|---|---|---|
| dyspneaRespiratory, thoracic and mediastinal disorders | 15/139 | 19/139 |
| Age, Categorical(Participants) | High Loading Dose of Ticagrelor | Conventional Loading Dose of Ticagrelor | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 75 | 80 | 155 |
| >=65 years | 54 | 53 | 107 |
| Age, Continuous(years) | High Loading Dose of Ticagrelor | Conventional Loading Dose of Ticagrelor | Total |
|---|---|---|---|
| Mean | 59.7 ± 9.47 | 58.8 ± 10.26 | 59.2 ± 9.46 |
| Sex: Female, Male(Participants) | High Loading Dose of Ticagrelor | Conventional Loading Dose of Ticagrelor | Total |
|---|---|---|---|
| Female | 40 | 45 | 85 |
| Male | 89 | 88 | 177 |
| Region of Enrollment(participants) | High Loading Dose of Ticagrelor | Conventional Loading Dose of Ticagrelor | Total |
|---|---|---|---|
| China | 129 | 133 | 262 |
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General Hospital of Chinese Armed Police Forces