TADCLOT- a Double Blind Randomized Controlled Trial

NCT06318481 | Completed Phase 3 DMC

• 1 other identifier: IRB-80/2023
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the safety and efficacy of a twice-daily Clopidogrel regimen vs. Ticagrelor in reducing major adverse events in patients undergoing primary PCI in a double-blind randomized controlled trial.

Conditions

Stent Thrombosis; Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (1)

• Evaluation of efficacy and safety

  Primary outcome measure is the difference in the composite of clinical events between the groups. Number of participants with death, recurrent myocardial infarction, stent thrombosis ,target lesion revascularization, and stroke.

  30 days

Secondary Outcomes (1)

• Secondary endpoint

  30 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

Patients will be provided ticagrelor twice daily for first 30 days after primary PCI.

Drug: Ticagrelor 90 MG

Control Group

ACTIVE COMPARATOR

Patients will be provided clopidogrel twice daily for first 30 days after primary PCI.

Drug: Clopidogrel

Interventions

Ticagrelor 90 MG DRUG

Patients in the treatment group will receive Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose for 30 days. After 30-day doses will be according to standards clinical practice guidelines.

Also known as: antiplatelet

Treatment Group

Clopidogrel DRUG

Patients in the control group will receive Clopidogrel 600 mg as a loading dose and 75 mg twice daily as a maintenance dose for 30 days. After 30-day doses will be according to standards clinical practice guidelines.

Also known as: antiplatelet

Control Group

Eligibility Criteria

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

You may qualify if:

• ST-segment elevation ≥1 mm in ≥ 2 contiguous ECG leads or New or presumably New left bundle branch block
• Age ≥18 years
• Written informed consent

You may not qualify if:

• Patients with STEMI secondary to stent thrombosis or index event being a complication of PCI within 30 days
• Thrombolytic therapy \<24 hours
• Platelet count \< 100,000 and Hemoglobin \<10 gm/dl
• Pregnancy or lactation
• Moderate to severe hepatic impairment
• Patients with advanced CKD and those on hemodialysis
• Recent ICH or major bleed requiring transfusion
• Inability to give informed consent
• Participation in another study
• Inability to fulfill protocol (living outside the city etc.)

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead
• PharmEvo Pvt Ltd: collaborator

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, 755000, Pakistan

Location

Related Publications (2)

• Hakeem A, Shah JA, Kumar R, Ali A, Lakho AA, Zeeshan H, Uddin MI, Khan K, Solangi B, Kumar M, Kumar M, Awan R, Ishaq H, Farooq F, Haq EU, Hameed A, Lehri WA, Zada S, Ali A, Raza A, Masood S, Humza A, Karim M; TADCLOT Investigators. Twice-Daily Clopidogrel vs Ticagrelor to Reduce Short-Term Major Adverse Cardiovascular Events After Primary Percutaneous Coronary Intervention: The TADCLOT Trial. J Am Coll Cardiol. 2025 Dec 9;86(23):2330-2345. doi: 10.1016/j.jacc.2025.08.041. Epub 2025 Aug 30.

  PMID: 40892606 DERIVED

• Hakeem A, Ali Shah J, Kumar R, Khan K, Zeeshan H, Lakho AA, Ali A, Uddin MI, Solangi B, Kumar M, Kumar M, Awan R, Dilawar F, Ishaq H, Farooq F, Ul Haq E, Hameed A, Lehri WA, Zada S, Raza A, Masood S, Humza A, Karim M. Rationale and design of the TADCLOT trial: A double blind randomized controlled trial comparing twice a day clopidogrel vs ticagrelor in reducing major cardiac events in patients with acute STEMI undergoing primary percutaneous coronary intervention. Am Heart J. 2025 Sep;287:141-150. doi: 10.1016/j.ahj.2025.03.021. Epub 2025 Apr 12.

  PMID: 40228593 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

• Abdul Hakeem

  NICVD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Care provider and investigator are same so both are blinded in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 19, 2024
• Study Start: February 19, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)