Efficacy and Safety of Early Combined Therapy with PCSK9 Inhibitors and Statins in Acute Ischemic Stroke (CAPTAIN)--A Multicenter, Prospective, Randomized Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study is an investigator-initiated, multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial (PROBE design) that includes patients with moderate or severe symptomatic intracranial large vessel atherosclerotic stenosis (sICAS) who present with acute ischemic stroke within 48 hours of symptom onset. Patients will be centrally randomized in a 1:1 ratio into two groups: Experimental Group: A single subcutaneous injection of 420 mg evolocumab upon admission, combined with standard doses of atorvastatin 20 mg or rosuvastatin 10 mg, along with other standard guideline-based medical treatments. Control Group: Standard doses of atorvastatin 20 mg or rosuvastatin 10 mg, with the remainder of treatment based on current guidelines. The primary objective of the study is to evaluate whether early combination therapy with a PCSK9 inhibitor and statins within 48 hours of symptom onset can reduce the incidence of early neurological deterioration in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The secondary objectives include comparing the effects of early PCSK9 inhibitor and statin combination therapy versus statin monotherapy on the 90-day neurological outcomes of AIS patients, improving early neurological recovery, and reducing the recurrence rate of stroke at 30 and 90 days. The safety objective is to assess whether the combination of early PCSK9 inhibitors and statins, compared to statin monotherapy, increases the incidence of moderate-to-severe systemic bleeding within 3 days post-randomization (based on the GUSTO scale), any type of intracranial hemorrhage (according to the ECASS III criteria), and all-cause mortality within 90 days.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• Acute ischemic stroke diagnosed by CT or MRI of the head.

• Symptom onset to randomization within 48 hours, including wake-up strokes or strokes without a witnessed onset. The time of symptom onset is defined as the last known normal time.

• NIHSS score ≤ 20.

• mRS score of 0-1 prior to the current stroke.

• Moderate or severe intracranial stenosis or occlusion (≥50%) confirmed by CTA, MRA, or DSA, involving the responsible intracranial arteries: intradural internal carotid artery, M1-2 segments of the middle cerebral artery, A1 segment of the anterior cerebral artery, V4 segment of the vertebral artery, basilar artery, or P1 segment of the posterior cerebral artery.

• The participant or legal representative has signed the informed consent form.

Locations
Other Locations
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Xiang Luo
flydottjh@163.com
133349893413
Backup
Yi Xie
yixie@tjh.tjmu.edu.cn
13026106657
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 416
Treatments
Experimental: PCSK9 inhibitors combined with atorvastatin/rosuvastatin
Sham_comparator: Atorvastatin/rosuvastatin
Related Therapeutic Areas
Sponsors
Collaborators: Hubei Xinhua Hospital, The Third People's Hospital of Hubei Province, Suizhou Hospital, Hubei University of Medicine, Hubei Shiyan People's Hospital, Wuhan Third Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Fifth Hospital of Wuhan, Minda Hospital Affiliated to Hubei University for Nationalities, Renmin Hospital of Wuhan University, Shanghai Zhongshan Hospital, Taihe Hospital, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Yichang Central People's Hospital
Leads: Xiang Luo

This content was sourced from clinicaltrials.gov