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Diabetes MellitusPhase 4TRACK-DNCT00786136

Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

A Phase 4 study testing rosuvastatin in people with Diabetes Mellitus and Chronic Kidney Disease, run by Shenyang Northern Hospital at 53 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Chronic Kidney Disease
What is being tested?
rosuvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,998 participants
Where
53 sitesChina
Study dates
Dec 2008to Nov 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned diagnostic coronary or peripheral artery angiography
  • T2DM
  • CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
  • Statin naive, or not on statin treatment for at least 14 days
  • Withdrawal metformin or aminophylline for 48h before angiography
  • Total iodixanol volume

Who cannot join

  • Hypersensitivity to iodine-containing compounds and statins
  • Type 1 diabetes mellitus
  • Ketoacidosis
  • Lactic acidosis
  • CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
  • STEMI
Show all 12Show fewer
  • NYHA class IV or hemodynamic instability
  • Administration of any iodinated CM within 14 days before randomization
  • LDL-C<1.82mmol/L（70mg/dL）
  • Hepatic dysfunction (ALT 3 times greater than upper normal limit)
  • Thyreoid insufficiency
  • renal artery Stenosis(unilateral >70％ or bilateral stenosis>50％)

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

China53 sites

  • General Hospital of Liaoning Anshan Iron and Steel Group Corporation

    Anshan, Liaoning, 114001

  • Chinese People's Liberation Army 252th Hostipal

    Baoding, Hebei, 610000

  • Baotou city central hospital

    Baotou, 014000

  • Baotou iron and steel group company worker hospital

    Baotou, 014040

  • The Armed Police General Hospital

    Beijing, Beijing Municipality, 100000

  • The Chinese people's liberation army general hospital affiliated hospitals

    Beijing, Beijing Municipality, 100000

  • Peking University first hospital

    Beijing, Beijing Municipality, 100034

  • General Hospital Of The Second Artillery Force of the PLA

    Beijing, Beijing Municipality, 100088

  • The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)

    Beijing, Beijing Municipality, 100853

  • CanZhou Central Hospital

    Cangzhou, Hebei, 610001

  • FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)

    Changchun, Jilin, 130011

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Changchun Central Hospital

    Changchun, Jilin, 130051

  • Chengdu Military General Hospital

    Chengdu, Sichuan, 610083

  • The Third Military Medical University, Chongqing Xinqiao Hospital

    Chongqing, Chongqing Municipality, 400037

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • Dongguan Kanghua Hospital

    Dongguan, Guangdong, 523080

  • Fushun central hospital

    Fushun, Liaoning, 113006

  • General Hospital of Guangzhou Military Command of PLA

    Guangzhou, Guangdong, 510010

  • The First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510120

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • General Hospital of Jinan Military Area Command of Chinese PLA

    Jinan, Shandong, 250031

  • The First Affiliated Hospital of Liaoning Medical College

    Jinzhou, Liaoning, 121001

  • The First Affiliated Hospital of Kunming Medical College

    Kunming, Yunnan, 650031

  • Kunming General Hospital of PLA

    Kunming, Yunnan, 650032

  • First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • NanJing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200025

  • ShenZhou Hopital Of ShenYang Medical College

    ShengYang, Liaoning, 110032

  • PLA 202 Hospital

    Shenyang, Liaoning, 110004

  • Shenyang Nortern Hospital

    Shenyang, Liaoning, 110016

  • Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine

    Shenyang, Liaoning, 110032

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110032

  • The 463th Hospital Of PLA

    Shenyang, Liaoning, 110042

  • Shijiazhuang International Peace Hospital

    Shijiazhuang, Hebei, 600082

  • 88th Hospital of the Chinese PLA

    TaiAn, Shandong, 271000

  • PLA 254 Hosipital

    Tianjin, Tianjin Municipality, 300142

  • Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces

    Tianjin, Tianjin Municipality, 300162

  • WuluMuqi General Hospital of PLA Lanzhou Military Area Command

    Ürümqi, Xinjiang, 830000

  • The First Affilliated Hospital Of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • The First Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325000

  • WuHan Asia Heart Hosital

    Wuhan, Hubei, 430022

  • WuHan Union Hospital Of China

    Wuhan, Hubei, 430022

  • TongJi Medical College HuaZhong University Of Science & Technology

    Wuhan, Hubei, 430030

  • Renmin Hospital Of Wuhan University

    Wuhan, Hubei, 430060

  • Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA

    Wuhan, Hubei, 430070

  • Xijing Hospital of the Fourth Military Medical University

    XiAn, Shanxi, 710032

  • Affiliated Hospital of Ningxia Medical College

    Yinchuan, Ningxia, 750004

  • HeNan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Being tested
rosuvastatin
Keywords
diabetes mellitus, chronic kidney disease, contrast induced acute kidney injury, angiography
Medical subject headings
Diabetes Mellitus, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00786136
Study groupRoleWhat they receive
1Experimentalperioperative rosuvastatin administration for at least 5 dosages
Receives: Drug: rosuvastatin
controlPlacebo comparatorblank control of perioperative statin administration
Receives: Drug: rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure

    Measured: 72 h

Secondary outcomes (1)

  1. The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.

    Measured: 30 d

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionOct 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,998 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00786136
Sponsor's protocol ID
SYNH-20081028
Acronym
TRACK-D
Status last verified
Apr 2013
First submitted
5 Nov 2008
Last updated
10 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Li J, Li Y, Wang X, Yang S, Gao C, Zhang Z, Yang C, Jing Q, Wang S, Ma Y, Wang Z, Liang Y, Han Y. Age, estimated glomerular filtration rate and ejection fraction score predicts contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease: insight from the TRACK-D study. Chin Med J (Engl). 2014;127(12):2332-6.

    PubMed 24931252

  • Han Y, Zhu G, Han L, Hou F, Huang W, Liu H, Gan J, Jiang T, Li X, Wang W, Ding S, Jia S, Shen W, Wang D, Sun L, Qiu J, Wang X, Li Y, Deng J, Li J, Xu K, Xu B, Mehran R, Huo Y. Short-term rosuvastatin therapy for prevention of contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease. J Am Coll Cardiol. 2014 Jan 7-14;63(1):62-70. doi: 10.1016/j.jacc.2013.09.017. Epub 2013 Sep 26.

    PubMed 24076297

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosuvastatin in people with Diabetes Mellitus and Chronic Kidney Disease, run by Shenyang Northern Hospital at 53 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure (time frame: 72 h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00786136, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.

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