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NCT Number: NCT01371058

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

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 .

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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；

routine dual antiplatelet

Drug

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

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

Primary outcomes

  1. reversion rate of HPR

    Time frame: 30 days

    reversion was defined as platelet aggregation <65%

Secondary outcomes

  1. major adverse cardiovascular events

    Time frame: 1 year

    including cardiac death, non-fatal myocardial infarction and target vessel revascularization

  2. Stent thrombosis and TIMI bleeding events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

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

Acronym: spirit

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 10, 2011
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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