---
title: "Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users"
nct_id: NCT01063426
overall_status: UNKNOWN
phase: PHASE4
sponsor: Hallym University Medical Center
study_type: INTERVENTIONAL
primary_condition: Thrombosis
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01063426.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01063426"
ct_last_update_post_date: 2010-02-05
last_seen_at: "2026-05-12T06:45:23.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users

**Official Title:** Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users Undergoing Total Knee Replacement Arthroplasty: RE-STOP-DVT Study- A Prospective Randomized Controlled Trial

**NCT ID:** [NCT01063426](https://clinicaltrials.gov/study/NCT01063426)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 180
- **Lead Sponsor:** Hallym University Medical Center
- **Conditions:** Thrombosis, Prevention, Surgery
- **Start Date:** 2009-11
- **Completion Date:** 2012-03
- **CT.gov Last Update:** 2010-02-05

## Brief Summary

Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty.

A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property.

We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients who are going to receive total knee replacement arthroplasty from any cause.
* \< 19 years old

Exclusion Criteria:

* patients with cancer
* Patients receiving anticoagulant agents from any cause
* current statin users
* expecting survival from other co-morbidity \< 1year
* Bed ridden patient
* AST, ALT \> 3times of upper normal limit
* CK\> upper normal limit
* pregnancy
* patients who receives hormone replacement therapy
```

## Arms

- **Atorvastatin + enoxaparine arm** (EXPERIMENTAL) — High dose atorvastatin arm before index surgery+ conventional enoxaparin
- **Conventional Enoxaprin** (ACTIVE_COMPARATOR) — Conventional Enoxaparin before 12hr and on 1-7th day after index surgery

## Interventions

- **High dose Atorvastatin+enoxaparin** (DRUG) — High dose atorvastatin 80mg/day for 7days after index surgery (total knee replacement arthroplasty, TKRA). At the same time Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered.
- **Enoxaparin** (DRUG) — Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.

## Primary Outcomes

- **Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities** _(time frame: 7days after index surgery)_

## Secondary Outcomes

- **D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP** _(time frame: 7days, 1month, 2month after index surgery)_

## Locations (1)

- Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery, Anyang-si, Gyeonggi-do, South Korea — _RECRUITING_

## 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)_
- `locations.hallym university sacred heart hospital, department of cardiology and orthopedic surgery|anyang-si|gyeonggi-do|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01063426.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01063426*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*