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

Coronary Artery Disease Clinical Trial

— spirit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371058
• Other study ID #: NH-20110530
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2011
• Last updated: December 15, 2015
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2015
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reversion rate of HPR	reversion was defined as platelet aggregation <65%	30 days	No
Secondary	major adverse cardiovascular events	including cardiac death, non-fatal myocardial infarction and target vessel revascularization	1 year	No
Secondary	Stent thrombosis and TIMI bleeding events		1 year	Yes