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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Shenyang Northern Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01371058
First received: May 31, 2011
Last updated: June 9, 2011
Last verified: April 2011
History of Changes
  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 on the top of dual antiplatelet treatment
 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:

U.S. FDA Resources

Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • Platelet aggregation induced by 20μmol/L ADP [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • major adverse cardiac events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Stent thrombosis and TIMI bleeding events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Routine therapy group
asprin 300mg/d for 1 month followed by 100mg/d chronically clopidogrel 75mg/d for 1year.
 Drug: routine dual antiplatelet
aspirin 300mg/d for 1 month followed by 100mg/d chronically clopidogel 75mg/d for at least 1 year
Experimental: high dose 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
Experimental: Policosanol treatment group
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 on the top of dual antiplatelet treatment
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

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

Contacts
Contact: Yaling Han, MD +86-24-23922184 hanyaling@263.net

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

No publications provided

Responsible Party: Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01371058     History of Changes
Other Study ID Numbers: NH-20110530
Study First Received: May 31, 2011
Last Updated: June 9, 2011
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Policosanol
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 16, 2013