Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE)

NCT03783351 | Active Not Recruiting DMC

• 1 other identifier: GUARANTEE
• Study Type: interventional
• Target: 4,009
• Locations: 1 country
• Sites: 9

Brief Summary

The aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19\*2 or \*3 allele and ticagrelor in carriers of a CYP2C19\*2 or \*3 allele in patients treated with new generation drug eluting stents.

Conditions

Acute Coronary Syndrome; Drug-Eluting Stents; Genotype; Angina, Stable

Outcome Measures

Primary Outcomes (1)

• Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)

  MACCE will include all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI) and ischemia driven revascularization at one-year follow-up.

  1 year

Study Arms (2)

Conventional Therapy

NO INTERVENTION

Patients randomized to the Conventional Therapy arm will receive either clopidogrel or ticagrelor, according to the clinical and procedural characteristics of patients. CYP2C19 genotyping will be performed at the end of study.

CYP2C19 Genotyping

ACTIVE COMPARATOR

CYP2C19 genotyping will be performed within 48 hours after randomization. CYP2C19 \*2 or \*3 reduced function allele patients will receive ticagrelor 90 mg bid, whereas non-\*2 or -\*3 CYP2C19 patients will receive clopidogrel 75 mg once daily.

Genetic: CYP2C19 genotype testing

Interventions

CYP2C19 genotype testing GENETIC

CYP2C19 genotype testing will be conducted in a designated central laboratory.

Also known as: clopidogrel, ticagrelor

CYP2C19 Genotyping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥18 years of age
• Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (SCAD)
• Patient has a percutaneous coronary intervention (PCI) indication and the new generation drug eluting stent(s) is successfully implanted

You may not qualify if:

• Patient unable to receive 12 months of dual anti-platelet therapy
• Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
• Contraindicated or allergic to clopidogrel or ticagrelor
• Patient or physician refusal to enroll in the study
• Patient having received thrombolytic therapy within the previous 24 hours
• Physician has known the patient's CYP2C19 genotype
• Anticipated discontinuation of dual anti-platelet therapy within the 12-month follow-up period, example for elective surgery
• History of intracranial hemorrhage
• Patient has a history of bleeding diathesis or coagulopathy
• Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
• Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
• Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
• Patient with cardiogenic shock or mechanical circulatory assist devices placed
• Patient with LVEF \<30%
• Patient with active liver diseases

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (9)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100000, China

Location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing Tong Ren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing LuHe Hospital

Beijing, Beijing Municipality, 101199, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Angina, Stable; Acute Coronary Syndrome

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Yujie Zhou, PhD,MD

  Beijing Anzhen Hospital

  STUDY CHAIR

• Xiaoli Liu, PhD, MD

  Beijing Anzhen Hospital

  STUDY DIRECTOR

• Xiaoteng Ma, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 21, 2018
• Study Start: May 27, 2019
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)