---
title: Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
nct_id: NCT01233167
overall_status: UNKNOWN
phase: NA
sponsor: Sir Run Run Shaw Hospital
study_type: INTERVENTIONAL
primary_condition: Coronary Artery Disease
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01233167.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01233167"
ct_last_update_post_date: 2011-07-20
last_seen_at: "2026-05-12T06:32:01.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation

**Official Title:** Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation

**NCT ID:** [NCT01233167](https://clinicaltrials.gov/study/NCT01233167)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 5232
- **Lead Sponsor:** Sir Run Run Shaw Hospital
- **Conditions:** Coronary Artery Disease
- **Start Date:** 2011-08
- **Completion Date:** 2013-05
- **CT.gov Last Update:** 2011-07-20

## Brief Summary

The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.

## Detailed Description

It is not clear that dual antiplatelet therapy is better than aspirin beyond 12-months period patients receiving sirolimus drug-eluting stent implantation. If aspirin plus clopidogrel reduced MACE rates without increasing blood events, the investigators will evaluate risk-benefit ratio. The investigators will observe all cause mortality, nonfatal myocardial infarction, or clinical-driven target vessel revascularization TVR in a 1-year trial duration. In addition, strokes, stent thrombosis, cardiac re-hospitalizations, dialysis/hemofiltration, duration of hospitalization and bleeding events will be observed.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age 18 years of older.
* The latest PCI with DES implantation before 12 months (stents must be one or more sirolimus-eluting stents).
* Angiographically confirmed major epicardial vessels (\>=2.5mm in diameter) without significant stenosis or restenosis (\>=50%).
* Geographically accessible and willing to come in for required study visits.
* Signed informed consent.

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to aspirin and clopidogrel.
* Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment and within 12 months.
* EF\<35% within 12 months.
* Severe cardiac valves disease, or idiopathic cardiomyopathy such as dilated cardiomyopathy, hypotrophic cardiomyopathy. Other severe system diseases.
* Previous ACS within 12 months.
* Previous stroke or transient ischemia attack within 12 months.
* Previous myocardial infarction and clinical-driven target vessel revascularization within 12 months.
* Current enrollment in another clinical trial.
* Suspected pregnancy.
* Big bleeding events within 12 months.
* Planned surgical procedure.
* Previous other type DES implantation or BMS implantation history.
* Extra-cardiac stent implantation history.
* Current or planned dialysis.
* The patient has a known hypersensitivity or contraindication to statins.
* Current or planned high dose and long-term glucocorticoid treatment.
* that is expected to limit survival to less than 1 years.
```

## Arms

- **clopidogrel** (EXPERIMENTAL)
- **placebo** (PLACEBO_COMPARATOR)
- **steply discontinued clopidogrel** (EXPERIMENTAL)

## Interventions

- **clopidogrel** (DRUG) — clopidogrel 75 mg po per day for 12 months
- **placebo** (DRUG) — placebo 75mg po per day for 12 months
- **clopidogrel and placebo** (DRUG) — clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months

## Primary Outcomes

- **all cause mortality** _(time frame: one year)_
- **nonfatal myocardial infarction** _(time frame: one year)_
- **clinical-driven target vessel revascularization** _(time frame: one year)_
- **cardiac death** _(time frame: one year)_
- **stent thrombosis** _(time frame: one year)_

## Secondary Outcomes

- **death** _(time frame: one year)_
- **myocardial infarction** _(time frame: one year)_
- **any repeat revascularization** _(time frame: one year)_
- **strokes** _(time frame: one year)_
- **dialysis/hemofiltration** _(time frame: one year)_
- **bleeding events** _(time frame: one year)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01233167.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01233167*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*