臨床研究等提出・公開システム

Dual AntiPlatelet Therapy for Stent Assisted Treatment of Cerebral Aneurysm
(DAPTS ACE)

DAPTS ACE

142

Safety Set : 23.1% (15/65 patients) in long-term Dual Anti Platelet Therapy (DAPT) group and 36.6% (26/71 patients) in short-term DAPT group was male. Age at the time of informed consent (mean*SD) :58.9*12.3 years-old in long-term DAPT group and 59.2*12.8 years-old in short-term DAPT group. No difference was observed in baseline charatics between two groups except the maximum flexion angle of indwelling part of stent treatment. *plus or minus

Of the 137 patients who started protocol treatment (65 patients in long-term DAPT group , 72 patients in short-term DAPT group), 135 patients continued the treatment for 3 months or more after surgery (65 patients in long-term DAPT group, 70patients in short-term DAPT group), 134 patients continued the treatment for 6 months or more after surgery (65 patients in long-term DAPT group, 69 patients in short-term DAPT group) and 133 patients continued the treatment for 12 months or more after surgery (64 patients in long-term DAPT group, 69 patients in short-term DAPT group)

Incidents of diseases or the like suspected of being due to the conduct of specified clinical trials based on the protocol which is required to report to the certified review board in accordance with Article 13 of the Clinical Trials Law: 4 cases were reported in long-term DAPT group: 1 case each of putaminal hemorrhage, subdural hematoma, subcutaneous bleeding and vascular stent occlusion 5 cases were reported in short-term DAPT group: 2 cases of cerebral infarction, each case of subcutaneous bleeding, drug rash, third cranial nerve palsy There was no death reported during the study period. Adverse events: 5 cases (7.7%) in long-term DAPT group, 11 cases (15.5%) in short-term DAPT group Adverse reactions: 5 cases (7.7%) in long-term DAPT group, 7 cases (9.9%) in short-term DAPT group Serious adverse events: 2 cases (3.1%) in long-term DAPT group, 1 case (1.4%) in short-term DAPT group

Analysis population for primary and secondary endpoints: FAS was 68 patients in short-term DAPT group and 65 patients in long-term DAPT group, excluding 3 patients who could not constitute events due to protocol treatment withdrawal before Single Anti Platelet Therapy (SAPT). (Primary Outcome) Event of ischemic stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm: 1 event was seen out of 68 patients in short-term DAPT group, but no event was seen in 65 patients of long-term DAPT group. Incidence rate of ischemic stroke (95% CI) was 0.0 /100 person-year(0.0~4.8)in long-term DAPT group and 1.5 /100 person-year(0.0~8.3)in short-term DAPT group. No statistically difference was found between the groups. (Logrank test P=0.332) Ischemic stroke event in short-term DAPT group was observed in patients who switched from Aspirin/Clopidogrel DAPT to Aspirin SAPT treatment. Supplemental analysis of PPS also showed similar results. (Secondary Outcome) <Time to occurrence of death and all stroke in 3 to 12 months after stent assisted embolization of intracranial aneurysm> Event of death and all stroke: 1 event was seen out of 65 patients in long-term DAPT group and 1 event was observed out of 68 patients in short-term DAPT group. Incidence rate of the event (95% CI) was 1.6 /100 person-year (0.0~8.9) in long-term DAPT group and 1.5 /100 person-year (0.0~8.3) in short-term DAPT group. <Time to occurrence of hemorrhagic event in 3 to 12 months after stent assisted embolization of intracranial aneurysm> Hemorrhagic event: 1 event was seen out of 65 patients in long-term DAPT group. Incidence rate of the event (95% CI) was 1.6 /100 person-year (0.0~8.9)in long-term DAPT group and 0.0 /100 person-year (0.0~4.4) in short-term DAPT group. <Time to occurrence of death, stroke and hemorrhagic event in 3 to 12 months after stent assisted embolization of intracranial aneurysm> Death, stroke and hemorrhagic event: 2 events were seen out of 65 patients in long-term DAPT group and one event was seen out of 68 patients in short-term DAPT group. Incidence rate of the event (95% CI) was 3.2 /100 person-year (0.4~11.6) in long-term DAPT group and 1.5 /100 person-year (0.0~8.3) in short-term DAPT group. <Time to occurrence of retreatment and stenosis or occlusion of the stent in 3 to 12 months after stent assisted embolization of intracranial aneurysm> Retreatment and stenosis or occlusion of the stent: 1 event was seen out of 65 patients in long-term DAPT group and 3 events were seen out of 68 patients in short-term DAPT group. Incidence rate of the event (95% CI) was 1.6 /100 person-year (0.0~9.0) in long-term DAPT group and 4.5 /100 person-year (0.9~13.2) in short-term DAPT group.

Incidence rate of the ischemic stroke events in 3 to 12 months under SAPT after 3 months of short-term DAPT after stent assisted embolization of intracranial aneurysm was low and no difference was confirmed compared to long-term use of DAPT. No evidence was found to support a positive recommendation for long-term DAPT for12 months after surgery.

Mar. 01, 2021

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs051180141

Sakai Nobuyuki

Kobe City Medical Center General Hospital

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

n.sakai@siren.ocn.ne.jp

Yamagami Hiroshi

National Hospital Organization Osaka National Hospital

2-1-14 Hoenzaka Chuo-ku Osaka-city Osaka Japan

+81-6-6942-1331

yamagami-brain@umin.ac.jp

Complete

June. 01, 2016

Interventional

randomized controlled trial

open(masking not used)

historical control

parallel assignment

treatment purpose

1 stent assisted embolization of intracranial aneurysm
2 receive aspirin and clopidogrel
3 Provided written informed consent within 30 days after embolization of intracranial aneurysm
4 20 year old or more
5 document informed consent

1 previous history of stent assisted embolization for target intracranial aneurysms in the past
2 withdraw anti platelet treatment is scheduled during study
3 acute ruptured (within 14 days)
4 history of allergy for aspirin or clopidogrel
5 inappropriate for withdraw DAPT at 3 months
6 baseline platelet count less than 100,000/mm3
7 need anti-coagulant treatment
8 intracranial hemorrhage or hemorrhagic tendency
9 any clinical evidence indicating the increase in bleeding risk by the investigators
10 inadequate for the study enrollment by the investigators

Both

intracranial aneurysm

3 months dual anti platelet treatment following stent assisted embolization of intracranial aneurys
12 months dual anti platelet treatment following stent assisted embolization of intracranial aneurysm

intracranial aneurysm

ischemic stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm

1 death and all stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm
2 hemorrhagic event during 3 to 12 months after stent assisted embolization of intracranial aneurysm 3 death, stake and hemorrhagic event during 3 to 12 months after stent assisted embolization of intracranial aneurysm
4 pretreatment and stenosis or occlusion go stent during 3 to 12 months after stent assisted embolization of intracranial aneurysm

+81-78-382-6669

Feb. 05, 2019

none