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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
high maintenance clopidogrel
routine dual antiplatelet
policosanol plus dual antiplatelet
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring high on-treatment platelet reactivity, percutaneous coronary intervention, stent thrombosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

routine dual antiplatelet

high maintenance clopidogrel

policosanol plus dual antiplatelet

Arm Description

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

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.

asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.

Outcomes

Primary Outcome Measures

reversion rate of HPR
reversion was defined as platelet aggregation <65%

Secondary Outcome Measures

major adverse cardiovascular events
including cardiac death, non-fatal myocardial infarction and target vessel revascularization
Stent thrombosis and TIMI bleeding events

Full Information

First Posted
May 31, 2011
Last Updated
December 15, 2015
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01371058
Brief Title
Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
Acronym
spirit
Official Title
Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
high on-treatment platelet reactivity, percutaneous coronary intervention, stent thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine dual antiplatelet
Arm Type
Active Comparator
Arm Description
asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.
Arm Title
high maintenance clopidogrel
Arm Type
Experimental
Arm Description
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.
Arm Title
policosanol plus dual antiplatelet
Arm Type
Experimental
Arm Description
asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.
Intervention Type
Drug
Intervention Name(s)
high maintenance clopidogrel
Intervention Description
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；
Intervention Type
Drug
Intervention Name(s)
routine dual antiplatelet
Intervention Description
clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
Intervention Type
Drug
Intervention Name(s)
policosanol plus dual antiplatelet
Intervention Description
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 Outcome Measure Information:
Title
reversion rate of HPR
Description
reversion was defined as platelet aggregation <65%
Time Frame
30 days
Secondary Outcome Measure Information:
Title
major adverse cardiovascular events
Description
including cardiac death, non-fatal myocardial infarction and target vessel revascularization
Time Frame
1 year
Title
Stent thrombosis and TIMI bleeding events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China

12. IPD Sharing Statement

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

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