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

NCT01371058 | Completed Phase 4 DMC

• 1 other identifier: NH-20110530
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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 .

Conditions

Coronary Artery Disease

Keywords

high on-treatment platelet reactivity; percutaneous coronary intervention; stent thrombosis

Outcome Measures

Primary Outcomes (1)

• reversion rate of HPR

  reversion was defined as platelet aggregation \<65%

  30 days

Secondary Outcomes (2)

• major adverse cardiovascular events

  1 year

• Stent thrombosis and TIMI bleeding events

  1 year

Study Arms (3)

routine dual antiplatelet

ACTIVE COMPARATOR

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

Drug: routine dual antiplatelet

high maintenance clopidogrel

EXPERIMENTAL

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

policosanol plus dual antiplatelet

EXPERIMENTAL

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

Interventions

high maintenance clopidogrel DRUG

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；

high maintenance clopidogrel

routine dual antiplatelet DRUG

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

routine dual antiplatelet

policosanol plus dual antiplatelet DRUG

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

policosanol plus dual antiplatelet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

policosanol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yaling Han, MD

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 10, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CN (1)