NCT02562651

Brief Summary

The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

July 26, 2015

Last Update Submit

December 10, 2016

Conditions

Vascular DiseasesCardiovascular DiseasesAcute Myocardial Infarction

Keywords

STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline

Outcome Measures

Primary Outcomes (1)

  • Changes in LV end-diastolic volumes index, %

    14 days and 6 month after STEMI

Secondary Outcomes (9)

  • Incidence of cardiovascular death,%

    14 days and 6 month after STEMI

  • Incidence of the recurrent myocardial infarction,%

    14 days and 6 month after STEMI

  • Incidence of the angina,%

    14 days and 6 month after STEMI

  • Incidence of the heart failure,%

    14 days and 6 month after STEMI

  • Incidence of the stroke,%

    14 days and 6 month after STEMI

  • +4 more secondary outcomes

Study Arms (2)

Doxycycline

EXPERIMENTAL

100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy

Drug: Doxycycline

Active comparator

ACTIVE COMPARATOR

Standard care for STEMI

Other: Standard care for STEMI

Interventions

DoxycyclineDRUG

Doxycycline bid for the first 7 days after primary anterior STEMI

Also known as: Doxycycline Solutab
Doxycycline
Standard care for STEMIOTHER

Invasive and medical treatment for STEMI according to guidelines

Also known as: Invasive and medical treatment for STEMI
Active comparator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)
  • ST-elevation Q wave myocardial infarction
  • term admission to an intensive care unit (ICU) in the first 24 hours of onset
  • the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction
  • written the informed consent to participate in research

You may not qualify if:

  • atrial fibrillation, a permanent form
  • valvular heart disease
  • severe comorbidity
  • acute heart failure according to the Killip classification IV FC (functional class)
  • history of chronic heart failure (NYHA III-IV)
  • poor image quality for Echocardiography
  • sinus bradycardia - heart rate of under 50 beats per minute, interventricular conduction delay (QRS \> 0,11 s.) and atrioventricular block II-III degree

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institutite for Cardiology

Tomsk, Tomskii Region, 634012, Russia

Location

MeSH Terms

Conditions

Vascular DiseasesCardiovascular DiseasesST Elevation Myocardial InfarctionVentricular Remodeling

Interventions

DoxycyclineStandard of Care

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Vyacheslav Ryabov, MD,PhD

    Research Institute for Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Research Institute for Cardiology

Study Record Dates

First Submitted

July 26, 2015

First Posted

September 29, 2015

Study Start

February 1, 2014

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

RU(1)