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出境医 / 临床实验 / Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial

Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial

Study Description
Brief Summary:
This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Unstable Angina Diabetes Mellitus Metformin Adverse Reaction Drug: Metformin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : June 17, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Metformin Continuation
Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography.
 Drug: Metformin
Continuation of Metformin
No Intervention: Metformin Interruption
Patients undergoing angiography will interrupt their metformin for 48 hours post angiography.
Outcome Measures
Primary Outcome Measures :
  1. Lactic Acidosis [ Time Frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) ]
    Lactate Level >5 mmol/L and HCO3<18


Secondary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) ]
    Rise in baseline creatinine >/= 25% or 27 umol/L

  2. All cause mortality at hospital discharge [ Time Frame: Duration of hospital admission ]
    Death in hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. On metformin therapy
  3. Angiography for ACS or elective non-ACS related indications
  4. Informed consent received

Exclusion Criteria:

  1. Cardiogenic shock prior to randomization
  2. Cardiac arrest prior to randomization
  3. Established severe CKD (eGFR<30, or on dialysis)
  4. Chronic liver disease
  5. Need for CABG within 48 hours of hospitalization
  6. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Contacts and Locations

Contacts
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Contact: Jay Shavadia, MD 3066553932 jss372@usask.ca

Locations
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Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N0W8
Contact: Jay Shavadia, MD    3066553932    jss372@usask.ca   
Principal Investigator: Jay Shavadia, MD         
Sub-Investigator: Rajan Minhas, MD         
Sub-Investigator: Haissam Haddad, MD         
Sub-Investigator: Colin Pearce, MD         
Sub-Investigator: Gudrun Caspar-Bell, MD         
Sub-Investigator: Alex Zhai, MD         
Sub-Investigator: Calvin Wells, MD         
Sub-Investigator: Jason Orvold, MD         
Sub-Investigator: Udoka Okpalauwaekwe, MBBS         
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Jay Shavadia, MD University of Saskatchewan, Department of Medicine, Division of Cardiology
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Lactic Acidosis [ Time Frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) ]
Lactate Level >5 mmol/L and HCO3<18
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Acute Kidney Injury [ Time Frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) ]
    Rise in baseline creatinine >/= 25% or 27 umol/L
  • All cause mortality at hospital discharge [ Time Frame: Duration of hospital admission ]
    Death in hospital
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
Official Title  ICMJE Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
Brief Summary This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Unstable Angina
  • Diabetes Mellitus
  • Metformin Adverse Reaction
Intervention  ICMJE Drug: Metformin
Continuation of Metformin
Study Arms  ICMJE
  • Experimental: Metformin Continuation
    Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography.
    Intervention: Drug: Metformin
  • No Intervention: Metformin Interruption
    Patients undergoing angiography will interrupt their metformin for 48 hours post angiography.
Publications *
  • Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD002967. doi: 10.1002/14651858.CD002967.pub4. Review.
  • Misbin RI, Green L, Stadel BV, Gueriguian JL, Gubbi A, Fleming GA. Lactic acidosis in patients with diabetes treated with metformin. N Engl J Med. 1998 Jan 22;338(4):265-6.
  • Oktay V, Calpar Çıralı İ, Sinan ÜY, Yıldız A, Ersanlı MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017 Nov;18(5):334-339. doi: 10.14744/AnatolJCardiol.2017.7836. Epub 2017 Oct 31.
  • Zeller M, Labalette-Bart M, Juliard JM, Potier L, Feldman LJ, Steg PG, Cottin Y, Roussel R. Metformin and contrast-induced acute kidney injury in diabetic patients treated with primary percutaneous coronary intervention for ST segment elevation myocardial infarction: Amulticenter study. Int J Cardiol. 2016 Oct 1;220:137-42. doi: 10.1016/j.ijcard.2016.06.076. Epub 2016 Jun 23.
  • Maznyczka A, Myat A, Gershlick A. Discontinuation of metformin in the setting of coronary angiography: clinical uncertainty amongst physicians reflecting a poor evidence base. EuroIntervention. 2012 Jan;7(9):1103-10. doi: 10.4244/EIJV7I9A175. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 17, 2020
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. On metformin therapy
  3. Angiography for ACS or elective non-ACS related indications
  4. Informed consent received

Exclusion Criteria:

  1. Cardiogenic shock prior to randomization
  2. Cardiac arrest prior to randomization
  3. Established severe CKD (eGFR<30, or on dialysis)
  4. Chronic liver disease
  5. Need for CABG within 48 hours of hospitalization
  6. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980990
Other Study ID Numbers  ICMJE OA-UofS-778
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jay Shavadia, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jay Shavadia, MD University of Saskatchewan, Department of Medicine, Division of Cardiology
PRS Account University of Saskatchewan
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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