GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ECRI bv
Sponsor:
Collaborators:
Biosensors International
AstraZeneca
The Medicines Company
Information provided by (Responsible Party):
ECRI bv
ClinicalTrials.gov Identifier:
NCT01813435
First received: February 12, 2013
Last updated: September 14, 2014
Last verified: September 2014

February 12, 2013
September 14, 2014
May 2013
June 2016   (final data collection date for primary outcome measure)
Composite of all-cause mortality or non-fatal new Q-wave MI [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
The composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
Same as current
Complete list of historical versions of study NCT01813435 on ClinicalTrials.gov Archive Site
Bleeding [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
The composite of investigator-reported BARC3 or BARC5 bleeding according to BARC definitions up to 2 years post randomisation.
Same as current
  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    All-cause mortality
  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Non-fatal new Q-wave MI
  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Ischemic stroke, including stroke of undetermined cause
  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Haemorrhagic stroke
  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Composite of all-cause mortality, stroke and non-fatal new Q-wave MI
  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Coronary revascularisation
  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Definite Stent Thrombosis according to the Academic Research Consortium
Same as current
 
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Comparative Effectiveness of 1 Month of Ticagrelor Plus Aspirin Followed by Ticagrelor Monotherapy Versus a Current-day Intensive Dual Antiplatelet Therapy in All-comers Patients Undergoing Percutaneous Coronary Intervention With Bivalirudin and BioMatrix Family Drug-eluting Stent Use

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

  • Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
  • Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

The study objective is to determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave MI compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy.

Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)).

All patients will be followed for a period of 2 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease (CAD)
  • Drug: Ticagrelor
    Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
    Other Name: Brilique
  • Drug: Acetylsalicylic Acid
    Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
    Other Names:
    • Aspirin
    • B01AC06
  • Drug: Clopidogrel

    Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

    Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy

    Other Names:
    • Plavix
    • B01AC04
  • Experimental: Experimental treatment strategy

    All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.

    Dosage and frequency:

    Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)

    Interventions:
    • Drug: Ticagrelor
    • Drug: Acetylsalicylic Acid
  • Active Comparator: Reference treatment strategy

    Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

    Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.

    Dosage and frequency:

    Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd

    Interventions:
    • Drug: Ticagrelor
    • Drug: Acetylsalicylic Acid
    • Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16000
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

-"All comer" patients

  1. Age ≥18 years;
  2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
  3. Able to provide informed consent and willing to participate in 2 year follow- up period.

Exclusion Criteria:

  1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
  2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
  3. Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
  4. Planned surgery, including CABG as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  5. Need for chronic oral anti-coagulation therapy;
  6. Active major bleeding or major surgery within the last 30 days;
  7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
  8. Known stroke (any type) within the last 30 days;
  9. Known pregnancy at time of randomisation;
  10. Female who is breastfeeding at time of randomisation;
  11. Currently participating in another trial and not yet at its primary endpoint.
Both
18 Years and older
No
Contact: Marieke Tuinman, MSc. +31654697953 mtuinman@cardialysis.nl
Contact: Linda Korthout, MSc. +31613230639 lkorthout@cardialysis.nl
Bulgaria,   Belgium,   Italy,   United Kingdom,   Australia,   Switzerland,   France,   Spain,   Denmark,   Hungary,   Germany,   Netherlands,   Austria,   Brazil,   Poland,   Romania,   Canada,   Singapore,   Sweden
 
NCT01813435
ECRI-12-001, 02EU11
Yes
ECRI bv
ECRI bv
  • Biosensors International
  • AstraZeneca
  • The Medicines Company
Study Chair: Patrick Serruys, Prof. MD. Thoraxcenter, Erasmus, The Netherlands
Principal Investigator: Marco Valgimigli, MD Universitaria di Ferrara, Italy
Principal Investigator: Pascal Vranckx, MD UZ Virga Jesse Ziekenhuis, Belgium
Principal Investigator: Stephan Windecker, Prof. MD Inselspital, University Hospital Bern Switzerland
Principal Investigator: Christian Hamm, Prof. MD Kerckhoff Klinik GmbH, Germany
Principal Investigator: Peter Juni, Prof. MD Bern University Hospital, Switzerland
Principal Investigator: Gabriel Steg, Prof. MD. C.H.U. Bichat - Claude Bernard, France
Study Director: Gerrit-Anne van Es ECRI, the Netherlands
ECRI bv
September 2014

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