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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01371058
First received: May 31, 2011
Last updated: December 15, 2015
Last verified: December 2015
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • reversion rate of HPR [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    reversion was defined as platelet aggregation <65%


Secondary Outcome Measures:
  • major adverse cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    including cardiac death, non-fatal myocardial infarction and target vessel revascularization

  • Stent thrombosis and TIMI bleeding events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: March 2011
Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371058

Locations
China, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Han Yaling, Dr, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01371058     History of Changes
Other Study ID Numbers: NH-20110530 
Study First Received: May 31, 2011
Last Updated: December 15, 2015
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
high on-treatment platelet reactivity
percutaneous coronary intervention
stent thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Clopidogrel
Policosanol
Anticholesteremic Agents
Antimetabolites
Hematologic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016