spirit: Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)

Sponsor

Shenyang Northern Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01371058

Collaborator

(none)

350

Enrollment

Location

Arms

30.1

Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice

The aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: high maintenance clopidogrel Drug: routine dual antiplatelet Drug: policosanol plus dual antiplatelet	Phase 4

Detailed Description

Thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice

Study Design

Study Type:

Interventional

Actual Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: routine dual antiplatelet asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.	Drug: routine dual antiplatelet clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
Experimental: high maintenance clopidogrel aspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year.	Drug: high maintenance clopidogrel clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
Experimental: policosanol plus dual antiplatelet asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.	Drug: policosanol plus dual antiplatelet aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months

Arm

Intervention/Treatment

Active Comparator: routine dual antiplatelet

asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.

Drug: routine dual antiplatelet

clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；

Experimental: high maintenance clopidogrel

aspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year.

Drug: high maintenance clopidogrel

clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；

Experimental: policosanol plus dual antiplatelet

asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.

Drug: policosanol plus dual antiplatelet

aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months

Outcome Measures

Primary Outcome Measures

reversion rate of HPR [30 days]
reversion was defined as platelet aggregation <65%

Secondary Outcome Measures

major adverse cardiovascular events [1 year]
including cardiac death, non-fatal myocardial infarction and target vessel revascularization
Stent thrombosis and TIMI bleeding events [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with coronary heart disease and had received coronary stenting
high on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by LTA)> 65% at 24 hr after clopidogrel loading (300 ~ 600mg)or 5 days after maintenance dose treatment (75mg / d)
Informed Consent

Exclusion Criteria:

receiving GP IIb / IIIa receptor antagonist treatment within 24h before enrollment
using cilostazol within 7d before enrollment
aspirin, clopidogrel or policosanol allergies
NYHA grade III ~ IV
planned elective coronary revascularization for multivessel coronary artery disease
long term warfarin treatment after persistent atrial fibrillation, valve surgery or other circumstance
Severe liver or kidney dysfunction
Active ulcer or a history of recent gastrointestinal bleeding
History of coagulation disorder, or recent history of active bleeding
history of intracranial hemorrhage within 6 months
Pregnancy
LDL less than 70mg/dL
Severe systemic diseases with life expectancy less than 1 year
planned surgery within next 6 months