NCT00979758

Brief Summary

The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after myocardial infarction who underwent intracoronary transfer of autologous bone marrow cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

6.4 years

First QC Date

September 17, 2009

Last Update Submit

January 23, 2018

Conditions

Myocardial InfarctionStem Cell TransplantationAngioplasty, Transluminal, Percutaneous Coronary

Outcome Measures

Primary Outcomes (1)

  • Changes in left ventricular ejection fraction from baseline to 12 months' follow-up

    12 months

Study Arms (4)

Atorvastatin

SHAM COMPARATOR

Atorvastatin routine dose

Drug: Atorvastatin and mononuclear cells transplantation

Intensive Atorvastatin

PLACEBO COMPARATOR

Atorvastatin Intensive dose

Drug: Atorvastatin and mononuclear cells transplantation

Atorvastatin+Transplantation

ACTIVE COMPARATOR

Atorvastatin routine dose+ Mononuclear cells Transplantation

Drug: Atorvastatin and mononuclear cells transplantation

Intensive Atorvastatin+Transplantation

EXPERIMENTAL

Atorvastatin intensive dose+ Mononuclear cells Transplantation

Drug: Atorvastatin and mononuclear cells transplantation

Interventions

Atorvastatin and mononuclear cells transplantationDRUG

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Also known as: Statin, Bone marrow stem cells transplantation
AtorvastatinAtorvastatin+TransplantationIntensive AtorvastatinIntensive Atorvastatin+Transplantation

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary disease undergoing PCI.
  • At most 2 months since last episode of ST-elevation myocardial infarction.
  • Left ventricular ejection fraction \>=20% \<=45% based on coronary angiography or echocardiography.

You may not qualify if:

  • Patients with non-ST-elevation myocardial infarction.
  • Patients with normal left ventricular function.
  • Patients with mechanical complications of myocardial infarction.
  • Patients with a malignant tumor.
  • Patients with infection disease.
  • Less than 6 months since last episode of stroke.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
  • Leukocytes less than 4,000/µL or exceeding 10,000/µL.
  • Platelets less than 100,000/µL.
  • Hemoglobin less than 10 g/dL.
  • Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
  • Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, 100037, China

Location

Related Publications (1)

  • Yang YJ, Qian HY, Song L, Geng YJ, Gao RL, Li N, Wang H, Tian XQ, Huang J, Huang PS, Xu J, Shen R, Lu MJ, Zhao SH, Wu WC, Wu Y, Zhang J, Qian J, Xu JY, Xiong YY. Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction. Open Heart. 2020 May;7(1):e001139. doi: 10.1136/openhrt-2019-001139.

    PMID: 32393654DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

AtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Yang yuejin, Doctor

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Fuwai hospital

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

CN(1)